Chemistry, Manufacturing and Controls (CMC) Consulting
SynRgee has extensive experience with development and manufacture
of small molecule and biologic drug substances and drug products
from lead compound selection to commercial manufacture.
SynRgee CMC consulting include:
- Medicinal chemistry consulting
- Process development and manufacture of small molecules and biologics
- Aseptic and non-aseptic drug product process development and manufacture
- Validation of drug substance and drug product manufacture
- Development and implementation of analytical methods and in-process / release specifications suitable for the phase of clinical development
- Clinical Trial Material (CTM) manufacture and logistics
- Identification and selection of vendors for outsourcing of CMC and CTM activities
- Assistance with writing CMC sections of INDs/IMPDs