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Pharma Regulatory – Simplifying Pharma Regulatory Compliance & Documentation

Our Pharma Regulatory Affairs software and consulting help pharmaceutical manufacturers and exporters meet global compliance requirements with confidence. From CTD/eCTD dossier preparation to post-approval lifecycle management, we support regulatory documentation and submissions for WHO, USFDA, EU-GMP, TGA, and other major agencies.

Achieve faster drug approvals, accurate regulatory submissions, and GMP documentation compliance with our expert-driven regulatory support services.

Key Regulatory Services

Dossier Compilation (CTD, eCTD, ACTD)

Drug Master File (DMF) Preparation & Filing

Pharma Product Registration Support

Country-Specific Submissions (90+ markets)

Regulatory Gap & Risk Analysis

Variation / Amendment Filing (Type I & II)

Labeling, Packaging & Artwork Compliance

Regulatory Due Diligence for M&A

Post-Marketing Surveillance Reporting

Agency Liaison & Response Handling

Explore Regulatory Services