CMC Regulatory Affairs Project

Focused on Plasma-Derived Therapies for Rare and Complex Diseases
  • Area: Cambridge, MA
  • Project Type: Regulatory Affairs

About this Project


Client requires on-going Subject Matter Expertise in global Chemistry Manufacturing Controls (CMC) Guidance and Submissions.


PSC® continues to support the Global Regulatory Affairs division for a large biopharmaceutical company, focused on plasma-derived therapies for rare and complex diseases. This company’s headquarters is in Cambridge, MA, but we support locations in the Greater Atlanta region and Greater Los Angeles region. PSC® has been critical in the development, coordination, and implementation of Global CMC Regulatory Strategies for various programs and tasks, PSC® is a key player in receiving approved submissions by the FDA, EMA, NMPA, and other global regulatory agencies in a timely manner for our client.


PSC® has successfully worked here on various Regulatory Affairs projects and has continuously had projects approved with global regulatory agencies.

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