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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
