|
• Project Management
• Evaluation and Management
of Contract Manufacturers (CMO’s)
• Negotiation of Manufacturing and Supply Agreements
• cGMP Bulk Drug Substance
Manufacturing
• cGMP Drug Product Manufacturing
• Technology Transfer to CMO’s
• Pharmaceutical Development
• Analytical
Assay Selection and Validation
• Specification Development
• QC Release and Stability Testing
• IND and
NDA Preparation
|