Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
News Medical

Pharmaceutical Regulatory Submission Preparation and Management

Regulatory submissions are packages of information and data needed by a regulatory agency to establish whether a regulated healthcare product can progress to clinical testing or whether it is safe and ...
EurekAlert!

Guidebook for drug regulatory submissions

Hoboken, New Jersey-April 22, 2009- The GUIDEBOOK FOR DRUG REGULATORY SUBMISSIONS (Wiley-Blackwell; $99.95; March 2009) by Dr. Sandy Weinberg is destined to become every regulatory director's ...

1 Day Mastering Generic CTD Submissions in the MENA Training Course: Specific Documentation and Study Requirements Essential for Successful Submissions (ONLINE EVENT: May 19, 2026)

Explore opportunities in mastering MENA's generic CTD submissions with expert-led insights. Harness regional expertise to streamline processes, minimize delays, and align with global strategies for ...
News Medical

Understanding regulatory submissions and the role of regulatory CMC project management

Any person engaged in a regulatory affairs CMC role should possess a robust combination of strategic experience and knowledge to ensure that CMC practices are undertaken in line with the requirements ...
Business Insider

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to ...