Organizational Support
In addition to our core technical and operational skill sets, Compass has a great deal of expertise in a variety of support functions in relation to managerial, regulatory and quality roles:
Interim Management—
  • Project Management;
  • Lead project teams;
  • Product development;
  • CMO oversight;
  • Person In Plant.

Technical and Regulatory Guidance—

  • Regulatory submissions;
  • Regulatory filings;
  • Regulatory documents;
  • IND, BLA, CTD, annual reports, amendments, supplements;
  • CMC drafting and review;
  • Regulatory inspections;
  • Pre-approval inspection preparation.


  • Due diligence;
  • Manufacturing audits;
  • Compliance audits;
  • CMO audits;
  • Vendor audits.
Compass Biotech What we do
Compass Biotech Blog
Compass Biotechnology Contract Management