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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.
Audits—
- Due diligence;
- Manufacturing audits;
- Compliance audits;
- CMO audits;
- Vendor audits.
