The Regulatory Affairs department ensures that Aishwarya group complies with all the regulations and laws pertaining to drug research, development and manufacturing in the countries where our products are manufactured and marketed This department works with federal, state and local regulatory agencies on issues affecting drug research and development. Pharmaceutical Regulatory Affairs is dedicated to ensuring the safety of a company’s pharmaceutical products. The division is responsible for ensuring that a drug promotion is not false or misleading and that the complete picture of a drug is given to the public. The Regulatory Affairs Department provides services like preparation and/or review of regulatory submissions to FDA and/or the respective regulatory agencies in the countries of business relevance.
The regulatory departmental staffs are well qualified in the area of pharmaceutical regulatory laws. As Aishwarya Group is a generic formulation manufacturer, we take special care to keep track of the current status on patents of proposed products. This enables us to avoid any infringement of patents and resultant lawsuits from existing patent holders. Aishwarya group outsources its intellectual property rights agenda to competent third parties in different countries. Our regulatory team consists of elite, highly qualified personnel engaged in providing data required to assure the high quality, efficacy and safety of our products. We can provide dossiers, documents, certificates and various studies for registration of our products as per guidelines of most health authorities in various countries.