Quality & Compliance
Sourced from reputed, regulated and accredited Indian manufacturers. Every batch complies with stringent international pharmacopeial specifications.
World Health Organization Good Manufacturing Practices for international public procurement.
Audited & ApprovedPharmaceutical Inspection Co-operation Scheme standards guaranteeing unified GMP compliance.
Harmonized GMPISO 9001:2015 & ISO 14001 certified quality management and environmental systems.
Standard CertifiedUS Food and Drug Administration registered and inspected manufacturing suites (where applicable).
Where Applicable* Note: Certifications refer to our manufacturing partners’ facilities and audited partner manufacturing sites.
End-to-End Quality Verification
Our dedicated regulatory and technical specialists audit every stage of product formulation, analytical assay, stability testing, and packaging integrity.
Partners with documented regulatory inspection histories and state-of-the-art facilities.
Full conformance with USP, BP, Ph. Eur., and IP pharmacopeial monographs.
CTD/eCTD dossier Modules 1 to 5, COPP, Free Sale Certificates, and technical clarifications.
Batch-to-batch assay consistency, validated dissolution profiles, and stability under Zone IVb conditions.
Responsive in-house regulatory affairs personnel directly assisting your ministry health filings.
Regulatory & Dossier Support Capabilities
We take the friction out of product registration in your destination market.
CTD / ACTD Dossiers
Fully compliant Modules 1–5 including administrative, summary, chemical/pharmaceutical, non-clinical and clinical documentation.
Zone IVb Stability Data
Accelerated and long-term stability studies conducted under 30°C/75% RH and 40°C/75% RH for hot and humid export markets.
COPP & Legalized Docs
Certificate of Pharmaceutical Product (WHO format), Free Sale Certificates (FSC), GMP certificates and embassy legalization.
Packaging & Artwork
Bilingual/multilingual packaging artwork adaptation compliant with your national drug authority guidelines.