| BDK Lifesciences Pvt. Ltd |
We provide complete solutions of registration from initial to final stage manufacturer / applicant for: Dossier compilation as per: ASEAN Common Technical Dossier (ACTD) Guidelines Common Technical Documents as per ICH format Regional Format (Country Specific) Handling queries Draft query reply Registration Management Documents Review BMR, MFR Process Validation reports Analytical Validation reports Stability Study reports, Dissolution profile, Certificate of analysis and related reports Writing Reports on: Bioavailability / Bioequivalence Studies, Clinical Trials studies Justification for fixed dose combination Prepare Periodic Safety Update report (PSUR) Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity. Prepare Summary of product (SPC), Pack Insert Prepare Expert Reports: Quality, Pre-clinical, Clinical
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