Pharmaceutical MedicineRegulatory Affairs

Regulatory Affairs in Pharmaceutical Industry: A dynamic entity

Regulatory Affairs In Pharmaceutical Industry

A medicine is essential for treating a disease. Thus care has to be taken that it is safe to use, has high efficacy in treating a disease without any adverse side effects and that’s where a regulatory professional plays a role. Regulatory affairs is essential aspect of each industry for controlling safety and efficacy of products such as pharmaceutical products i.e. medicines, pesticides, agrochemicals, cosmetics, complementary and alternative medicines and medical devices. Thus from the initiation of the trial, testing, packaging and marketing world over a regulatory professional is required so that the company is omitted from making any error at ant step of the drug formulation and thus preventing the company from losing money and their reputation. Hence to maintain the standardization of products available in market we need professionals to handle these regulatory aspects at various levels. They also are bridge between the pharmaceutical companies and the Governments world over as they need to follow the norms laid out by each government organization before marketing the product in that region as well as maintaining all the relevant data, documents and procedures implied by the organization. The regulatory professional leads and guides the team for a successful end result of drug acceptance.

Role of Regulatory Professionals

Regulatory affairs professional are considered as guardians of human health, ensuring safety and efficacy of drugs both during trials as well as ensuring transparency during marketing. Regulatory professionals keep track of changing legislations passed by government in aspect of the product being marketed as well as help in  obtaining marketing authorization from regulatory agencies by providing and maintaining the required documents. Their technical advice is essential at every aspect of the product development from initiation, packaging, marketing and launching for commercial and scientific viability of the product. The regulatory affairs departments is constant evolving with new rules, legislations hence an individual needs to keep pace with the changing dynamics as lesser the taken for a product to reach the market the better will be the economic growth of the company as time and accuracy is a critical factor.

Online Regulatory Affairs Courses Offered

James Lind institute provides an opportunity for clinicians, pharmacy and life science graduates for a sound purposeful job as regulatory experts by providing online regulatory affairs courses which are recognized internationally.

The courses offered:

Advanced Post Graduate Diploma in Clinical Research and Regulatory Affairs

Advanced Post Graduate Diploma in Pharmacovigilance and Medical writing

Advanced Post Graduate Diploma in Pharmacovigilance and Regulatory affairs

Professional Diploma in Clinical Data Management

Advanced Post Graduate Diploma in Quality assurance.

JLI aids in boosting skills and knowledge with industry experts and mentors. For more information please visit

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