News & Insights
Regulatory Requirements Across the Product Development Lifecycle
Join Biologics Consulting's Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, as she leads a three-part Virtual Workshop Series with Cambridge Healthtech Institute titled "Regulatory Requirements Across the Product Development Lifecycle." Part 1: Tuesday, October…
CE Marking Medical Devices: The Process, Part 2 – New EU Medical Device Regulations
Overview Interested in gaining access to the European market with your medical device or combination product? This multi-part webinar series details the requirements for obtaining approval to market medical devices in the European Economic Area (EEA). Topics will include comparison of CE Marking requirements…
CE Marking Medical Devices: The Process, Part 1 – EU vs. FDA Comparison
Overview Interested in gaining access to the European market with your medical device or combination product? This multi-part webinar series details the requirements for obtaining approval to market medical devices in the European Economic Area (EEA). Topics will include comparison of CE Marking requirements…
CMC Requirements for Cell and Gene Therapy
Overview After decades of setbacks, Cell and Gene Therapy (CGT) - one of the most talked-about innovations in the industry - has made major strides in recent months. Since August 2017, the FDA has approved three gene therapy products. Most recently, the Agency announced the approval of Luxturna, which…
A Risk-Based Approach to Analytical and Formulation Development of Biopharmaceuticals: Optimizing your Strategy will Reduce Cost and Development Time
Overview The risk-based approach to analytical and formulation development fundamentally shifts the way many sponsors and manufacturers think about the product development process for biopharmaceutical products, moving away from a minimalistic approach and toward a strategic, forward-looking methodology…
Clinical and Regulatory Considerations for Orphan Drug Applications
Overview The development of Orphan Drugs - those developed specifically to treat rare medical conditions - is growing at an astounding rate. In 2014, nearly 41%1 of all new product approvals from the FDA were for the treatment of rare diseases - a trend that is expected to continue as the exclusivity…
The Value of Analytics for Achieving Successful Manufacturing Process Transfer
Overview The biopharmaceutical product development lifecycle often requires the transfer of a manufacturing process from one facility to another. These transfers can occur at any point along the development path, and may be driven by increases in material needs to support clinical studies or the commercial…