CMC Regulatory Affairs Project
- 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.