RA

Regulatory Foundation | Start with the End in Mind

Regulatory Foundation | Start with the End in Mind

In generic drug development, technical skills alone are not enough. What truly ensures timely success is strong regulatory planning—right from Day 1. Before you even begin pre-formulation work or touch any excipient, you must sit with your Regulatory Affairs team and carefully plan how the product will be registered. This includes understanding FDA requirements, patent…

Role of Regulatory Affairs Professionals in the Pharmaceutical Industry

Role of Regulatory Affairs Professionals in the Pharmaceutical Industry

The role of regulatory affairs professionals in the pharmaceutical industry is to ensure compliance with regulatory requirements and guidelines set by various regulatory authorities. ​ They play a crucial role in the development, approval, and post-marketing surveillance of pharmaceutical products. ​ Some specific responsibilities of regulatory affairs professionals include: ​ Regulatory Strategy Development They are…

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