Regulatory Affairs (RA) also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, Import, Export and Cosmetics. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals. The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing.
The drug development process is a lengthy, complex and extremely costly albeit necessary process. Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug. Throughout the development stages, pharmaceutical companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans.
Regulatory Affairs also ensures the maintenance of the marketing licence and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage etc.. Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.
In this highly regulated environment, BARROLEX plays a critical role not only as the interface with health agencies and as a link between different departments in the company but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug. BARROLEX professionals keep working with the authorities and different departments within the company in order to meet regulatory commitments with the health authorities.
BARROLEX provides exceptional value to the clients by rendering top-quality; cost-effective, customized, innovative, and timely drug regulatory services. We take responsibility and accountability for project performance and strive to create a solution-based relationship. We are identified as one of the reliable providers of Drug Regulatory related Services, Custom Duty & Freight Forwarding that are appreciated by our national as well as international clients.
BARROLEX currently has clients in the United Kingdom, Republic of china and the United States of America and has provided technical guidance to them. Clients' projects have ranged from import to registration to new chemical entity registration to clinical phase. Various qualified personnel are appointed in to provide maximum benefit to the clients for availing Custom Duty & Freight Forwarding and Drug Regulatory Services. We also provide regulatory consulting services to pharmaceutical, medical device, biotech, FSSAI, and other medical companies to help them expand and retain their presence in the Indian markets.
