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Regulatory Services
₹ 25,100 / Month Get Latest Price
Service Features
| Availability | In Stock |
GST No - 33AAECS3826P1Z0 | Member since 2026
Prestige Center Point, 313, Level 3- 7, Cunningham Road Bengaluru - 560052, Karnataka, India
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Service Details
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)
Star Drugs & Research Laboratories Limited
Prestige Center Point, 313, Level 3- 7, Cunningham Road Bengaluru - 560052, Karnataka, India
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