From Development to
How Well Do You Know Your Product
Chemistry, Manufacturing and Controls
(CMC) for drugs is an important and
detailed section in dossiers that supports
clinical studies and marketing applications.
The drug used during clinical trials must
have similar Quality Attributes as what you
intend to market.

Manufacturers must know what steps and
variables in the manufacturing process
need to be controlled and why. Process
understanding is the foundation for control
of manufacturing.

Providing Support, Review, and Project
Management for:

  • CMC Dossier Preparation
  • ICH Stability Compliance
  • Raw Material & Excipient Quality
  • CMO Auditing & MFG Oversight
  • Manufacturing Procedures
  • Critical Process Parameters (CPP)
  • Critical Quality Attributes (CQA)
  • Container/Closure
  • Establishment of Specifications
  • Process & Analytical Methods Tech
CMC Tech Xfer  Inquiry
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About CMC/Tech
Transfer  Assistance