Regulatory and Compliance
Our Regulatory Affairs Department acts as a liaison between the FDA and the Company. It comprises of seasoned Regulatory professionals having both technical and regulatory expertise wit mor than 30 years experience.
RA is responsible for getting the FDA approval for the company’s new generic drug products. Regulatory Affairs reviews the data critically, ensures the adequacy and completeness of the information, compile and submit high quality dossiers with the FDA.
Regulatory Affairs serves as a facilitator between the R&D scientist and the FDA in understanding the requirements of a specific drug product during the early development stage.
Regulatory Affairs provides critical due diligence during the acquisition of ANDAs.
Regulatory Affairs is responsible for keeping the company and the technical teams up to date on the latest FDA guidelines and regulatory intelligence. Regulatory Affairs provide strategical direction to the R&D team and company to interpret the guidelines while bringing affordable generic drugs to the market quickly.
Our RA Department maintains the company’s drug products throughout their life cycle, which involves monitoring and handling the post approval submissions, periodic adverse event reports, maintaining the drug product labeling current and compliant with the current regulations and other compliance related activities.
Wherever required Regulatory Affairs represent and provides company’s perspective on a proposed regulation/guideline from the regulatory agencies.
