Regulatory Affairs Compliance – APC Pharma

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Regulatory Affairs

Compliance

Regulatory filings of Generics ANDA/ANDS

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.

Services

Contact Us

Dilip Patel: 0012159179234

Dr Rajendra: +919664894484

Mr Bhavesh: +919638043307

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