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CDSCO, DCA & NABL Compliance

Regulatory Support & Dossier Services

Seamless compilation of Module 3 Quality (CMC) technical dossiers in eCTD format, impurity qualification, and regulatory agency audit representation.

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CTD & eCTD Dossier Compilation

Preparation of Module 3 (CMC) quality dossiers for ANDA, NDA, MAA, and CDSCO Form 29/44 applications.

Pharmacopoeial Compliance

Method alignment and monograph gap analysis across Indian (IP), United States (USP), British (BP), and European (EP) pharmacopoeias.

Impurity Qualification

Structure elucidation, toxicity threshold determination (TTC), and ICH Q3A/B impurity qualification reports.

DMF Filing Support

Type II Drug Master File (DMF) technical writing, LOA issuance assistance, and annual update management.

Deficiency Query Resolution

Expert scientific response drafting for CDSCO queries, DCA regulatory reviews, and international health authority validation questions.

Stability Protocol Execution

Designing and executing ICH Q1A(R2) stability protocols for Zone IVb submission packages.

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