Pharmaceutical Projects
A partial list of projects in which Cardinal Consulting and Training has assisted clients and continues to advise:
- Design Test Methods
- Validate Test Methods
- Preparation for a Pre-Approval Inspection
- Good Manufacturing Practices (GMP) audit of pharmaceutical firms
- Good Manufacturing Practices (GMP) audit of contractors to pharmaceutical firms
- Manufacturing
- Testing
- Packaging
- GMP audits of suppliers to pharmaceutical firms
- Raw Material
- Labels
- Rubber Stoppers
- Containers
- Design and Present GMP Training Courses
- Design and Present Management Training Courses on Effective Communications, Negotiations, and more
- Review NDA with special concern for the Chemistry, Manufacturing, and Controls section (CMC)
- Appraise conditions for contract packaging arrangement between firms
- Prepare Drug Master File (DMF)
- Accompany clients to meetings with the FDA
- Consult/assist regarding firm’s compliance with a Consent Decree
