News & Insights
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…
Biologics Consulting Unveils New Brand Identity; Launches Expert Edge Webinar Series Providing Participants Access to Top Consultants
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, has launched a rebranding effort that includes the introduction of new brand positioning, as well as a new logo and interactive website. In conjunction with the…
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…