Chandresh Bodh

I am Ms. Chandresh Bodh, with over 7.5 years experience in RA CMC, with a Master’s degree in pharmacy from Mahamaya Technical University, Noida, India.

Currently working as a “Sr. Officer Regulatory Affairs in Florencia Healthcare pvt. Ltd.

v Preparation, Compilation and Review of high-quality CMC documents for regulatory submission of new registrations, renewal projects and post approval changes.

v Knowledge of EU procedures, i.e., CP, NP, MRP, DCP, product lifecycle management and Market Authorization (MA) compliance.

v Follow-up with clients and regulatory authorities to obtain timely product approval.

v Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.

v Solutioning approach, ability to build new capabilities, take ownership and deliver projects per client requirements.

v Response for deficiency letters from various regulatory authorities.

v Knowledge of review and assessment of CMC supporting technical document for like Pharmaceutical Development Report (PDR), Analytical Validation Report (AMV), Process Validation Report (PVR), MSDS, DMF, Specification, Testing procedures & Certificate of analysis (API, Excipients, Finish product & Packing material), stability documents and Summary of Product Characteristics.

v Prepare & review content for Artwork (Printed carton, Printed alu. Foil, Label and Inserts etc.)

v Coordination with the plant for technical requirements for the compilation of dossiers.

v Research oriented with experience in literature review and technical writing.

v Formulation discussion for applying Permission, COPP, FSC Manufacturing License & Product permission with QA, QC, Production & Drug department.

v Keeping track of registration status and supplying additional documents required by them from time to time.

v Knowledge of current regulatory guidelines.

I have done master in pharmacy in pharmaceutics from mahamaya technical university, Gautam buddh nagar, India.