BOUTIQUE SERVICES  

  For Documents
  1. ComplyWell Solutions can prepare or review a variety of regulatory documents to ensure quality and regulatory compliance. This will help you to save precious internal resources which can be better utilized for on-site work:

    1. Site Master File (for WHO GMP)
    2. Partnership Agreements
    3. Quality Agreements
    4. SOPs
    5. Product Development Reports
    6. Site Master File (for WHO GMP)
    7. Validation Reports (Analytical Method, Manufacturing Process and Equipment)
    8. Stability Study Protocols and Reports
    9. Development Safety Update Reports
    10. Periodic Safety Update Reports
    11. Clinical and Non-clinical Study Reports
    12. Annual Product Reports
    13. CMC, non-clinical and clinical sections of ANDAs and NDAs

    (Note: This service can also be performed on-site when required)