Bhandhavi Daram

Responsible for CMC submissions including post approval variations, renewals, responding to HAQs within stipulated timelines. Preparation of modules 3 and 2.3 for the submissions. Review and assessment of the regulatory impact of CMC changes proposed post approval of the drug product through online Track Wise®, RADAR. Constant tracking of the approval status in the market REGISTER, OPAL. Involved in the Regulatory strategy document for innovation projects, in liaison with the cross functional teams.

• Involved in the analytical method development, validation and method transfer activities by following SOPs, GMPs and HSE requirements. Review SOPs, protocols and reports of method development and validation. Prepare the 3.2.P.8 and 3.2.P.5 modules as required for the dossier submission. • Acquainted with software applications like GLIMS (Laboratory Information Management System), Track wise (Quality Management Software) and other relevant instrument handling application software.

• Involved in the preparation of Patent Landscape Reports for sterile products, including ophthalmic and parenteral products. • Preparation of analytical search reports using patent and non-patent search databases: Scifinder, Espacenet, Patentscope, Google Patents, Indian Patent Office (IPO), US Patent and Trademark Office, Google Scholar, Science Direct, PubMed.

• Developmental activity of the generic products majorly focused on Parenterals which involves both liquid and lyophilized products for injection. • Design and conduct of the developmental studies for the generic formulation of the drug product and to check the stability of the same as per the ICH guidance for stability testing.

Pharmaceutical Analysis

Pharmaceutical Sciences