The Regulatory Affairs department plays an integral and crucial role in the organizational structure. Externally it is the key interface between the principal companies and the regulatory authorities. Main activities include the registration and renewal of manufacturing companies and their products for the local market, clearance activities, product variation submission, product recall activities, pharmacovigilance etc. for products like Pharmaceutical Products, Herbal Products, Health Products, Medical Devices, Perfume and Cosmetics, Baby Milk Products and Food Products. Internally it liaises between various departments in order to meet regulatory commitments with the authorities. The quality, safety and efficacy of our products in the market is ensured by strictly complying with the local rules and regulations. The highly qualified and well experienced Regulatory Pharmacists that keep up to date with changes in regulatory legislation and guidelines and that continuously ensure quality standards are met and submissions meet strict deadlines while liaising with principal companies.
An adverse drug reaction (ADR)/Side Effect or adverse event is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is either suspected to be related to the drug or irrespective of whether the drug is suspected to be the cause.