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.
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