BDK Lifesciences Pvt. Ltd

Aditional Information

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 Our customized services • Interaction with regulatory authorities • Preparation and conduct of meetings with authorities • Development of Product regulatory strategies • Preparation of development plans • Project planning for regulatory activities through all phases of drug development • Preparation and review of Module 1 CTD documents (e.g. application form, proposed product information and drug labeling) • Preparation, review and submission of regulatory documents in CTD documents • Evaluation of technical data prior to submission (quality, clinical and non-clinical documents) • Management of follow – up activities after submission