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 the Food and Drug Administration (FDA) to initiate clinical trials in humans. This authorization is secured through the submission of an Investigational New Drug (IND) application. What is an IND […]
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 this question to more than 1000 people that are involved in PDF preparation for regulatory submissions; of organizations of all sizes. We wanted to share the results of this survey; […]
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, demonstrating their safety and efficacy through a rigorous regulatory review process. PMA submissions hold immense importance for medical device manufacturers seeking market authorization for their innovative creations. They ensure patients […]
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 United States, manufacturers must demonstrate its compliance with these regulations. This is where the 510(k) premarket notification comes in. A 510(k) submission is an application submitted to the FDA before […]
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 in a document called a New Drug Application (NDA). An NDA is a comprehensive package submitted to regulatory authorities by drug developers. It essentially tells the full story of a […]
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 Drug Application. Unlike a New Drug Application (NDA), which is a much more intensive process required for entirely new, innovative drugs, ANDAs provide a streamlined pathway for generic versions of […]
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 task becomes even more daunting when multiplied across various clients, each with their own unique requirements and expectations. What are the challenges of these companies, though? In this landscape, […]
Report Generation Automation with DocShifter (with a practical demo)
Are you creating your reports manually today? Or perhaps using complex submission publishing tools to build your reports? Investigational medicinal product dossiers (IMPD), clinical study reports (CSR), annual reports, training manuals, standard operating procedures (SOP) and even full 510k & PMA submissions could all benefit from a tool designed specifically for their creation. Merging multiple […]
‘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 document compliance earlier’? It is actually a pretty simple concept. Instead of validating the PDF files for compliance with the submission itself (after the draft publishing stage), why not create […]
How to create compliant PDFs & reports from a browser in 3 clicks with DocShifter
Spending countless hours preparing PDF documents for submissions, using Adobe Acrobat or other PDF editing tools? Tired of manually going through every single page to detect issues with table of contents, paragraphs, font sizes, hyperlinks, white spaces and other non-compliance elements? Today, content preparation for regulatory submissions can be automated. Much faster, allowing you & […]