PHASE-APPROPRIATE, SCALABLE QUALITY SYSTEM:

• Standard Operating Procedures (SOPs)

• Documentation Management (paper-based and electronic)

• Vendor Qualification and Management Program

• Training Program

• Product Disposition

• Quality Agreements

Vendor Management and Quality Oversight:

• Project Management & Collaborations with CMC/CMO teams

• Quality Operations

  • Master and Executed Batch Records Review

  • Deviations, CAPA, Investigations, and Complaints Management

  • Technology and Analytical Method Transfers

  • Product Disposition

  • Stability Studies Oversight

FOREIGN AND DOMESTIC CGMP AUDITS OF:

• Starting Materials, Intermediates, Drug Substance, and Drug Product Manufacturers

• Contract Laboratories

• Contract Packagers and Labelers

• Distributors, Biorepositories and Depots

REGULATORY AFFAIRS SUPPORT:

• IND (IMPD), NDA, and ANDA preparations support