Radha Bhati

Background

About Radha Bhati

Production Manufacturing of products as per cGMP requirement for export and domestic market. Participation in the GMP audit for the approval of new product and facility. Compilation and on line documentation during execution of commercial batches. Provide training to the staff as per cGMP requirements. Execution of commercial batches. To Provide support to the R&D scientist for the technology transfer of new product for submission and commercial production. Technology Transfer As per the requirement of Business Development Team providing the feed back for the area, equipment and tooling finalization. Execution of trial batch. Finalization of Stability study protocol and testing of trial batch. Procurement of raw material and finalization of specification for new raw material. Commutation to the client in case of technical quires related to the product. Provide the executed document to the regulatory affairs department for data submission. Sending product to the analytical department for analysis and provide support. Provide the necessary documents for the execution of site and tech transfer products. Finalization of HGC composition and Tooling as per client requirement for loan license products. Execution of trial batch and provide the competitive analytical results to the client. Preparation of trial batch summary report for all the trial batches. Preparation of MFR, PEP, Stability protocol, Hold time protocol as per the requirement. Regulatory Affairs Document review for regulatory dossier submissions, including Review of technology transfer documents of new products MFC, BMRs, BPRs, BE reports, etc. Regulatory Compliance of analytical Studies, including review of stability studies, analytical validations, specifications, standard test procedures, etc. Compilation of regisatrion and re-egisatrion dossier for ROW- market and handling of regulatory quires. Providing registration sample to the regulatory agency.