Discover our blog & thought leadership content.
AI Applied In Content Preparation: Translation & Redaction
Why does AI in Regulatory Content Preparation Matter? As artificial intelligence technology continues to evolve, its use cases in regulatory content preparation are becoming
510k Submission Checklist
510k submission checklist Get access to all 510(k) submission formatting specifications via our downloadable checklist. Enter your email below, and download the PDF version right
How To Automatically Check MS Word Documents for Compliance with DocShifter
Manual document preparation for compliance can be both time-consuming and error-prone. Regulatory teams often struggle with ensuring that all documents meet the necessary formatting, style,
FDA eCTD Validation Criteria: A Comprehensive Guide
The electronic Common Technical Document (eCTD) has revolutionized the drug development and approval process. By standardizing the format for regulatory submissions, the eCTD has streamlined
Practical PDF preparation examples to make your life easier
The Role of PDFs in Regulatory Submissions: Navigating Challenges and Ensuring Compliance in the Life Sciences Industry PDFs play a crucial role in the life
DocShifter Named Top Innovator in Regulatory Software Providers List!
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way people dealt with documents in regulated industries: life
Achieving Regulatory Excellence: Must-Have Attributes
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making timely, informed decisions. We wanted
Everything About Marketing Authorisation Application (MAA) Submissions
An MAA submission is a comprehensive dossier submitted by a pharmaceutical company to regulatory authorities seeking permission to market a new medicinal product. In this
CTA Submissions: Guidance, Process & Requirements
What is a Clinical Trial Application (CTA)? A Clinical Trial Application (CTA) is a formal request submitted to regulatory authorities to conduct a clinical trial
Biologics License Application (BLA) Guide
Imagine you’ve developed a new medicine that uses living things, like cells or proteins, to fight disease. This medicine is called a biologic product. BLA
Investigational New Drug (IND) Application Process: An A-Z Guide
The development of safe and effective new drugs is a cornerstone of the pharmaceutical industry. A critical step in this process is obtaining approval from
Practical PDF preparation automation examples and their benefits for you
“ Where do you spend the most time preparing PDFs for use in submissions? ” This was the starting point for this webinar. We asked
PMA Submissions: Guidance, Process & Requirements
PMA (Premarket Approval) Submissions: Guidance, Process & Requirements Premarket Approval (PMA) submissions are the cornerstone of obtaining FDA clearance for high-risk Class III medical devices,
A Complete Guide to 510(k) Submissions for Medical Devices (2024)
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. To bring a new medical device to market in the
What are New Drug Applications? A Complete Guide to NDAs
“How do new medications make it to the pharmacy shelves or to the patients? What steps does it need to go through?” The answer lies
ANDA Submissions: Guidance, Process & Requirements
Have you ever wondered how affordable generic medications reach the market? The answer lies in a process known as an ANDA submission, or Abbreviated New
The Impact Of 3-click Document Compliance On The Operations of CROs & Regulatory Service Providers
Preparing compliant content while there’s a deadline hanging above your head is not easy. Particularly for clinical research organization (CRO) and regulatory service providers. The
‘Achieve Document Compliance Earlier in Submissions’ — What does this even mean?
If you ever attended one of our webinars, you will have heard us say this a lot. But, what do we actually mean by ‘achieve
Navigating the Regulatory Submission Process
Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work
3 Click Compliance: What does it mean? How does it work?
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up
Ennov Acquires DocShifter, the Ultimate Document Conversion Software for Regulated Enterprises
Paris, France – February 6, 2024 Ennov, provider of the only cloud-based unified compliance platform for life sciences – a highly configurable software architecture that
How to automate PDF submission content preparation to speed up publishing
1. Save hundreds of hours every month when preparing PDFs for submission-readiness If regulatory operations teams could have a wish, one would be to have
The Risks of Manual PDF Manipulation in Life Sciences Compliance (and the benefits of automation)
Introduction Welcome to a journey through the complexities of PDF compliance within the life sciences. This article aims to enlighten you on various critical aspects:
Achieving Regulatory Excellence: Must-Have Attributes
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D
Automation in OpenText Documentum with DocShifter
1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward
How To Render Veeva Binders With DocShifter: Webinar Key Takeaways
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the process and ensuring submission-ready PDF reports. Binders are being used by almost
The impact of automated PDF checking & fixing at a large pharma company: A customer case study by DocShifter
Introduction: “Converting to PDF is easy, and everyone does that. The problem is us spending hours and hours of time on editing PDFs with Acrobat,
eCTD Global Aspects and Future Directions (LinkedIn Live Session)
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group. During this LinkedIn live session, Mr. Yamaguchi and Paul Ireland
![[Webinar Summary] How to automate PDF rendering with DocShifter featured image](https://www.docshifter.com/wp-content/uploads/2023/06/featured-image-1-6489aedde2b47-1024x576.webp)
[Webinar Summary] How to automate PDF rendering with DocShifter
1. Do not wait until the last minute to resolve content-related issues A typical drug development process takes from 5 and 15 years, and documentation is
Accelerating submission-ready PDF rendering. A case story by PharmaLex.
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and
5 ways to automate your submission content preparation in Veeva with DocShifter
Here are 5 ways to automate submission content preparation in Veeva with DocShifter 1. Achieve document compliance earlier in your submission process when using DocShifter with
4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry
Regulatory Professionals Community on LinkedIn
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many
eCTD 4.0: Key Changes & Impact on Submission Content Preparation
Who is (unfortunately) old enough to remember this? Date: March 2007. A submission. 500 binders for Module 5, 60 binders for Module 4, 30 binders
Creating the right environment for structured and unstructured data to co-exist
There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such
A Case Study in Regulatory Operations: Digital Transformation of the Workforce
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or
What is Document Rendering, and what can it mean for your business?
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more
Pharma time-to-market reduced thanks to more efficient submission document publishing services
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of
How to reduce regulatory content creation issues? 4 tips.
Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been
Free checklist for PDF format specifications for FDA submissions
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
3 tips to save time and reduce risk in regulatory submissions
How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the
Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?
Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track
Is data taking over the role of PDF in eCTD submissions?
The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with
Refusal to File: Reducing FDA Non-compliance Risk
Understanding Refusal to File (RTF) in the FDA Approval Process The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and
Successful eCTD Implementation in China: 3 Lessons Learned
China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development
Frequently asked questions on the eCTD submission format (Part 1)
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences
Achieving Regulatory Excellence: Must-Have Attributes
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making timely, informed decisions. We wanted
Achieving Regulatory Excellence: Must-Have Attributes
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D
New FDA Forms for INDs, NDAs, and BLAs: What to Know Before Submitting
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information
eCTD Global Aspects and Future Directions (LinkedIn Live Session)
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group. During this LinkedIn live session, Mr. Yamaguchi and Paul Ireland
The Economics of Technology Innovation in Regulatory
With so many mature and emerging digital technologies, and no end of interesting use cases in Regulatory, how do we decide which ones are worth
4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry
Regulatory Professionals Community on LinkedIn
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many
The Evolving State of Global Dossier Management
Global dossier management is a hot topic for many small and large organizations in life sciences. Global dossier management is a challenging concept on its
eCTD 4.0: Key Changes & Impact on Submission Content Preparation
Who is (unfortunately) old enough to remember this? Date: March 2007. A submission. 500 binders for Module 5, 60 binders for Module 4, 30 binders
Creating the right environment for structured and unstructured data to co-exist
There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such
A Case Study in Regulatory Operations: Digital Transformation of the Workforce
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or
AI Applied In Content Preparation: Translation & Redaction
Why does AI in Regulatory Content Preparation Matter? As artificial intelligence technology continues to evolve, its use cases in regulatory content preparation are becoming
3 Click Compliance: What does it mean? How does it work?
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up
How to automate PDF submission content preparation to speed up publishing
1. Save hundreds of hours every month when preparing PDFs for submission-readiness If regulatory operations teams could have a wish, one would be to have
Automation in OpenText Documentum with DocShifter
1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward
How To Render Veeva Binders With DocShifter: Webinar Key Takeaways
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the process and ensuring submission-ready PDF reports. Binders are being used by almost
3 ways to automate Report Generation with DocShifter
1. For the viewer, a report is just a series of PDF files. But for the author(s), a report means a lot of hard (manual)
[Webinar Summary] How to automate PDF rendering with DocShifter
1. Do not wait until the last minute to resolve content-related issues A typical drug development process takes from 5 and 15 years, and documentation is
Accelerating submission-ready PDF rendering. A case story by PharmaLex.
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and
5 ways to automate your submission content preparation in Veeva with DocShifter
Here are 5 ways to automate submission content preparation in Veeva with DocShifter 1. Achieve document compliance earlier in your submission process when using DocShifter with
3 Click Compliance: What does it mean? How does it work?
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up
What is OCR? A Guide on Optical Character Recognition
A Complete Guide to Optical Character Recognition (OCR) In today’s fast-paced world, businesses need practical solutions to tackle everyday challenges efficiently. One such solution is
The impact of automated PDF checking & fixing at a large pharma company: A customer case study by DocShifter
Introduction: “Converting to PDF is easy, and everyone does that. The problem is us spending hours and hours of time on editing PDFs with Acrobat,
[Webinar Summary] How to automate PDF rendering with DocShifter
1. Do not wait until the last minute to resolve content-related issues A typical drug development process takes from 5 and 15 years, and documentation is
Dynamic Scalability in Document Conversion: What is it?
In today’s digital age, organizations are generating and handling an unprecedented amount of digital documents in various file formats. From invoices and reports to contracts
5 ways to automate your submission content preparation in Veeva with DocShifter
Here are 5 ways to automate submission content preparation in Veeva with DocShifter 1. Achieve document compliance earlier in your submission process when using DocShifter with
The Importance of File Format Preservation in the context of Archiving
File Format Preservation: What is it? File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It
What You Should Know About Document Transformation Services
Mass digital document transformation is one of those things that your business might only need once or twice. System migration, archiving or regulatory requirements are
What is Document Rendering, and what can it mean for your business?
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more
What is the PDF/A format, and how to use the PDF/A format for your Digital Archive
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare or other regulated industries carry a heavy backlog
How to design or implement an enterprise file conversion platform?
What is enterprise file conversion? What does it mean? Enterprises or businesses deal with a lot of documents, in multiple formats. Word, Excel, PowerPoint, PDF,
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
6 Rocking Reasons to Rethink Document Rendering
We have been rendering various documents into a unified format such as PDF for many years now. For many reasons: ease of use, accessibility, a
6 Valuable Tips: Why should you convert to PDF?
Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical
How Docker puts your rendering farm on steroids
Infinite scalability in document conversion through container technology Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost
5-Step Automation: Reduce Risks in Correspondence Tracking and your incoming e-mail conversion
Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very
Why you should update your file format from time to time
In an earlier post we explained the importance of digital preservation and why every company should have a digital preservation strategy. As a company, you want
The Importance of File Format Preservation in the context of Archiving
File Format Preservation: What is it? File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It
What is Document Rendering, and what can it mean for your business?
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more
What is the PDF/A format, and how to use the PDF/A format for your Digital Archive
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare or other regulated industries carry a heavy backlog
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
How to speed up PDF conversion by 10X in 2021
Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A, video and audio files. All these digital files need
How Docker puts your rendering farm on steroids
Infinite scalability in document conversion through container technology Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost
Why and how to preserve your digital archive?
The volume of digital information is increasing at warp-time speed. Whether created as a result of the digitising of non-digital collections, as a digital publication
DocShifter Named Top Innovator in Regulatory Software Providers List!
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way people dealt with documents in regulated industries: life
Ennov Acquires DocShifter, the Ultimate Document Conversion Software for Regulated Enterprises
Paris, France – February 6, 2024 Ennov, provider of the only cloud-based unified compliance platform for life sciences – a highly configurable software architecture that
Compliant file format transformation on Microsoft Azure Marketplace
We are thrilled to announce that DocShifter is now available on the Microsoft Azure Marketplace! For those customers that are seeking to deploy DocShifter in
The impact of automated PDF checking & fixing at a large pharma company: A customer case study by DocShifter
Introduction: “Converting to PDF is easy, and everyone does that. The problem is us spending hours and hours of time on editing PDFs with Acrobat,
Expansion to India! Exciting times ahead. (Press Release)
Win-win for partners, customers and end-users “We are very pleased to strengthen our global presence through this valuable partnership” said Geert Van Peteghem, CEO
Accelerating submission-ready PDF rendering. A case story by PharmaLex.
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and
Pharma time-to-market reduced thanks to more efficient submission document publishing services
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of
PeopleScout significantly improves efficiency and speed in document and PDF conversion with DocShifter
PeopleScout Technology, a world leader in recruitment process outsourcing (RPO) has recently chosen DocShifter to convert all incoming digital formats to high quality PDF files.
DocShifter powers the document conversion solution in Generis new CARA cloud offering
We are happy to announce our DocShifter software will be the default enterprise document conversion solution in Generis’ new CARA cloud offering. The integration will
AI Applied In Content Preparation: Translation & Redaction
Why does AI in Regulatory Content Preparation Matter? As artificial intelligence technology continues to evolve, its use cases in regulatory content preparation are becoming
510k Submission Checklist
510k submission checklist Get access to all 510(k) submission formatting specifications via our downloadable checklist. Enter your email below, and download the PDF version right
How To Automatically Check MS Word Documents for Compliance with DocShifter
Manual document preparation for compliance can be both time-consuming and error-prone. Regulatory teams often struggle with ensuring that all documents meet the necessary formatting, style,
FDA eCTD Validation Criteria: A Comprehensive Guide
The electronic Common Technical Document (eCTD) has revolutionized the drug development and approval process. By standardizing the format for regulatory submissions, the eCTD has streamlined
Practical PDF preparation examples to make your life easier
The Role of PDFs in Regulatory Submissions: Navigating Challenges and Ensuring Compliance in the Life Sciences Industry PDFs play a crucial role in the life
DocShifter Named Top Innovator in Regulatory Software Providers List!
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way people dealt with documents in regulated industries: life
Achieving Regulatory Excellence: Must-Have Attributes
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making timely, informed decisions. We wanted
Everything About Marketing Authorisation Application (MAA) Submissions
An MAA submission is a comprehensive dossier submitted by a pharmaceutical company to regulatory authorities seeking permission to market a new medicinal product. In this
CTA Submissions: Guidance, Process & Requirements
What is a Clinical Trial Application (CTA)? A Clinical Trial Application (CTA) is a formal request submitted to regulatory authorities to conduct a clinical trial
Biologics License Application (BLA) Guide
Imagine you’ve developed a new medicine that uses living things, like cells or proteins, to fight disease. This medicine is called a biologic product. BLA
Investigational New Drug (IND) Application Process: An A-Z Guide
The development of safe and effective new drugs is a cornerstone of the pharmaceutical industry. A critical step in this process is obtaining approval from
Practical PDF preparation automation examples and their benefits for you
“ Where do you spend the most time preparing PDFs for use in submissions? ” This was the starting point for this webinar. We asked
PMA Submissions: Guidance, Process & Requirements
PMA (Premarket Approval) Submissions: Guidance, Process & Requirements Premarket Approval (PMA) submissions are the cornerstone of obtaining FDA clearance for high-risk Class III medical devices,
A Complete Guide to 510(k) Submissions for Medical Devices (2024)
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. To bring a new medical device to market in the
What are New Drug Applications? A Complete Guide to NDAs
“How do new medications make it to the pharmacy shelves or to the patients? What steps does it need to go through?” The answer lies
ANDA Submissions: Guidance, Process & Requirements
Have you ever wondered how affordable generic medications reach the market? The answer lies in a process known as an ANDA submission, or Abbreviated New
The Impact Of 3-click Document Compliance On The Operations of CROs & Regulatory Service Providers
Preparing compliant content while there’s a deadline hanging above your head is not easy. Particularly for clinical research organization (CRO) and regulatory service providers. The
‘Achieve Document Compliance Earlier in Submissions’ — What does this even mean?
If you ever attended one of our webinars, you will have heard us say this a lot. But, what do we actually mean by ‘achieve
Navigating the Regulatory Submission Process
Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work
3 Click Compliance: What does it mean? How does it work?
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up
Ennov Acquires DocShifter, the Ultimate Document Conversion Software for Regulated Enterprises
Paris, France – February 6, 2024 Ennov, provider of the only cloud-based unified compliance platform for life sciences – a highly configurable software architecture that
How to automate PDF submission content preparation to speed up publishing
1. Save hundreds of hours every month when preparing PDFs for submission-readiness If regulatory operations teams could have a wish, one would be to have
The Risks of Manual PDF Manipulation in Life Sciences Compliance (and the benefits of automation)
Introduction Welcome to a journey through the complexities of PDF compliance within the life sciences. This article aims to enlighten you on various critical aspects:
Achieving Regulatory Excellence: Must-Have Attributes
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D
What is OCR? A Guide on Optical Character Recognition
A Complete Guide to Optical Character Recognition (OCR) In today’s fast-paced world, businesses need practical solutions to tackle everyday challenges efficiently. One such solution is
Automation in OpenText Documentum with DocShifter
1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward
How To Render Veeva Binders With DocShifter: Webinar Key Takeaways
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the process and ensuring submission-ready PDF reports. Binders are being used by almost
Compliant file format transformation on Microsoft Azure Marketplace
We are thrilled to announce that DocShifter is now available on the Microsoft Azure Marketplace! For those customers that are seeking to deploy DocShifter in
New FDA Forms for INDs, NDAs, and BLAs: What to Know Before Submitting
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information
3 ways to automate Report Generation with DocShifter
1. For the viewer, a report is just a series of PDF files. But for the author(s), a report means a lot of hard (manual)
The impact of automated PDF checking & fixing at a large pharma company: A customer case study by DocShifter
Introduction: “Converting to PDF is easy, and everyone does that. The problem is us spending hours and hours of time on editing PDFs with Acrobat,
Expansion to India! Exciting times ahead. (Press Release)
Win-win for partners, customers and end-users “We are very pleased to strengthen our global presence through this valuable partnership” said Geert Van Peteghem, CEO
eCTD Global Aspects and Future Directions (LinkedIn Live Session)
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group. During this LinkedIn live session, Mr. Yamaguchi and Paul Ireland
[Webinar Summary] How to automate PDF rendering with DocShifter
1. Do not wait until the last minute to resolve content-related issues A typical drug development process takes from 5 and 15 years, and documentation is
Dynamic Scalability in Document Conversion: What is it?
In today’s digital age, organizations are generating and handling an unprecedented amount of digital documents in various file formats. From invoices and reports to contracts
Accelerating submission-ready PDF rendering. A case story by PharmaLex.
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and
5 ways to automate your submission content preparation in Veeva with DocShifter
Here are 5 ways to automate submission content preparation in Veeva with DocShifter 1. Achieve document compliance earlier in your submission process when using DocShifter with
The Economics of Technology Innovation in Regulatory
With so many mature and emerging digital technologies, and no end of interesting use cases in Regulatory, how do we decide which ones are worth
The Importance of File Format Preservation in the context of Archiving
File Format Preservation: What is it? File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It
4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry
Regulatory Professionals Community on LinkedIn
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many
The Evolving State of Global Dossier Management
Global dossier management is a hot topic for many small and large organizations in life sciences. Global dossier management is a challenging concept on its
eCTD 4.0: Key Changes & Impact on Submission Content Preparation
Who is (unfortunately) old enough to remember this? Date: March 2007. A submission. 500 binders for Module 5, 60 binders for Module 4, 30 binders
Creating the right environment for structured and unstructured data to co-exist
There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such
A Case Study in Regulatory Operations: Digital Transformation of the Workforce
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or
What You Should Know About Document Transformation Services
Mass digital document transformation is one of those things that your business might only need once or twice. System migration, archiving or regulatory requirements are
What is Document Rendering, and what can it mean for your business?
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more
What is the PDF/A format, and how to use the PDF/A format for your Digital Archive
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare or other regulated industries carry a heavy backlog
Pharma time-to-market reduced thanks to more efficient submission document publishing services
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of
How to design or implement an enterprise file conversion platform?
What is enterprise file conversion? What does it mean? Enterprises or businesses deal with a lot of documents, in multiple formats. Word, Excel, PowerPoint, PDF,
How to reduce regulatory content creation issues? 4 tips.
Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been
Free checklist for PDF format specifications for FDA submissions
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
6 Rocking Reasons to Rethink Document Rendering
We have been rendering various documents into a unified format such as PDF for many years now. For many reasons: ease of use, accessibility, a
3 tips to save time and reduce risk in regulatory submissions
How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the
Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?
Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track
Is data taking over the role of PDF in eCTD submissions?
The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with
Refusal to File: Reducing FDA Non-compliance Risk
Understanding Refusal to File (RTF) in the FDA Approval Process The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and
How to speed up PDF conversion by 10X in 2021
Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A, video and audio files. All these digital files need
DocShifter 6.3 is rocking rendering again with new and improved functionality
DocShifter 6.3 was born as a result of our development team’s hard work. This release is very special to us, not only because it adds
