Regulatory Affairs is essential in the pharmaceutical sector, particularly throughout the drug development process, which is lengthy, intricate, and highly expensive, yet indispensable.
Numerous pharmaceutical firms seek external Regulatory Affairs team members with specialized knowledge to guarantee that products are developed, manufactured, and maintained to meet the highest standards of quality, safety, and efficacy. Experienced consultants are essential to ensure that all filing and submission objectives are accomplished with excellence and within the designated timelines.
- The function of Regulatory Affairs in the pharmaceutical sector throughout the lifecycle of a medicinal product:-
- Following the drug discovery phase, where potentially viable compounds are evaluated for their non-clinical properties, the clinical phases—ranging from early to late stages—commence to further assess the safety and efficacy of the drug candidate. Upon the successful completion of clinical trials, it is necessary to obtain marketing approval for the medicinal product by submitting a marketing authorization application.
- Once the competent authorities grant the marketing authorization, the commercialization of the medicinal product can commence. However, the regulatory affairs team will continue to submit post-approval amendments through variations to ensure that the dossier approved by regulators remains current.
- In the subsequent section, we will examine in detail the various phases of a drug’s lifecycle and the integral role that Regulatory Affairs plays within the pharmaceutical industry.