Regulatory and Compliance
Our Regulatory Affairs (RA) Department serves as the primary liaison between the FDA and the Company. The department is comprised of seasoned regulatory professionals with both technical and regulatory expertise and more than 30 years of industry experience.The RA team is responsible for securing FDA approvals for the Company’s new generic drug products. Regulatory Affairs critically reviews scientific and technical data, ensures the adequacy and completeness of information, and compiles and submits high-quality regulatory dossiers to the FDA.Regulatory Affairs also acts as a key facilitator between R&D scientists and the FDA by helping development teams understand regulatory requirements for specific drug products during the early stages of development.In addition, the department provides critical regulatory due diligence support during the acquisition of ANDAs.The RA team keeps the Company and its technical teams informed of the latest FDA guidelines, regulatory updates, and industry intelligence. Regulatory Affairs provides strategic guidance to the R&D organization in interpreting regulatory requirements while supporting the rapid development and commercialization of affordable generic drug products.Throughout the product life cycle, the RA Department is responsible for maintaining regulatory compliance for the Company’s drug products. This includes managing post-approval submissions, preparing periodic adverse event reports, ensuring product labeling remains current and compliant with applicable regulations, and overseeing other compliance-related activities.Where required, Regulatory Affairs also represents the Company and provides its perspective on proposed regulations and guidance issued by regulatory agencies.
