Regulatory Services

₹25,100.00 / Month

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Description

Dossier Preparation Asean Common Technical Dossier (ASCTD)Common Technical Dossier (CTD)Drug Master File (DMF) Dossier Compilation & Submission For EuropeAustraliaNew ZealandAfricaAsiaLatin AmericaCIS (Commonwealth of Independent States) CountriesGCC (Gulf Cooperation Council) CountriesBRIC CountriesOther ROW markets. Draft Data For -BMR, MFR-Process Validation & Analytical Validation-Stability Study reports-Dissolution profile-Certificate of Analysis & related reports Complilation Of -Bioavailability / Bioequivalence studies-Justification for fixed dose combination-Prepare Periodic Safety Update reports (PSUR) Prepare Summary Of -Summary of Product Characteristics (SmPC)-Patient Information Leaflet (PIL)-label and carton content-Product Development Overview (Module 2) -Clinical-Non Clinical-Non Clinical Study Reports (Module 4)-Clinical Study Reports (Module 5)

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