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 & […]
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 into success. Therefore, navigating regulatory submissions is a critical and often complex hurdle. The regulatory submissions process involves 5 main stages, being: Pre-submission Application preparation Submission & review Addressing deficiencies […]
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 and simplify the way you prepare content for submissions today. DocShifter Express. What is DocShifter Express (DS Express)? DocShifter Express is a browser-based platform that simplifies and streamlines various […]
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 delivers a consistent user experience and eliminates data silos – is proud to announce today the acquisition of DocShifter, a trusted global leader in document transformation software. With this acquisition, […]
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 all documents formatted properly, according to the guidelines. Unfortunately, even when external and internal resources work with perfectly-styled Microsoft Word templates, it is no surprise that almost everyone has their […]
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: Gaining insights into the complex process of manual PDF preparation for compliance. Learning about the numerous challenges and limitations associated with manual PDF manipulation. Discovering how automation revolutionizes submission content […]