Regulatory Affairs and Compliance

Sai Pharma Solutions Inc. has a strong Regulatory group. Advisors from Japan, Canada, Europe, ASEAN Countries and US to have specific advice. The group has a good client list and has many US, PMDA, Japan and European approvals to their credit.

  • Regulatory filings of Generics ANDA/ANDS etc. to US, Europe, Canada, Japan, ASEAN Countries and Row market
  • Technical Data Package Development at R&D stage of product
  • Drug Master Files for APIs, Excipients and Packaging Materials
  • CEP/COS for European Pharmacopoeial Products(EDQM)
  • USP Verification( Drug Substances and Excipients)
  • Dossier compilation as per Common technical dossier (CTD/eCTD) format/ Asian Common Technical Dossier (ACTD) Guidelines / South Africa (MCC-MRF-1) Guidelines/ Brazil ANVISA Guidelines.
  • Critical Review of Dossier and Preparation of GAP Analysis Report
  • CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
  • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Mfg. Formula, Mfg. Process etc.
  • Consulting and preparation of all five ¬†CTD modules (M-1, M-2, M-3, M-4, M-5) for registration purpose in any country .
  • Re-formatting old Dossier/DMF, NTA to CTD/eCTD format.
  • Regulatory Compliance Audits
  • Guidance and Counseling of Pharma students
  • Training and Development of Pharmacists, RA/QA/QC/ADL Associates
  • Grooming and Mentoring future leaders in Pharma ADL/QC/RA/QA/
  • R & D/Clinical field
  • Response preparation to the customer and regulatory authorities queries