Accelerating your drug development and approval
Drug development & approval

Regulatory & quality management support

CMC REGULATORY SERVICES

Pharmavize guarantees that its advice is in line with the latest CMC guidelines and directives. We deliver solutions and recommendations that allow you to develop an optimal CMC strategy. Pharmavize’s services will provide support with:

  • Data management
  • Technical & regulatory writing (Module 3):
    - IMPDs and INDs
    - Marketing authorization dossiers
    - Variations & Updates
  • Dossier publishing & submission (eCTD)

Our expertise covers a.o.:

  • Small and large molecules
  • Vaccines
  • Monoclonals
  • Advanced therapies

 

QUALITY MANAGEMENT SERVICES

Compliance and performance are your goals. But they don’t just happen. Pharmavize can provide GMP quality management support to help you design and implement an effective GMP pharmaceutical system.

  • Global GMP audits
  • Product-specific audits
  • SOP writing and implementation
  • Follow-up assessment and continuous improvement
  • Product quality reviews
  • Internal audits, including ‘mock’ inspection audits