CMC Regulatory Affairs Project
- Area: Cambridge, MA
- Project Type: Regulatory Affairs
About this Project
OBJECTIVE
Client requires on-going Subject Matter Expertise in global Chemistry Manufacturing Controls (CMC) Guidance and Submissions.
SERVICES
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.
PROJECT SUCCESS
PSC® has successfully worked here on various Regulatory Affairs projects and has continuously had projects approved with global regulatory agencies.
Related Projects
Greater Los Angeles Facility Expansion
Greater Los Angeles Varied Services
Greater Los Angeles Cleaning Validation
How Can We Help You?