Pepa Lopez Barragan is a trusted expert in regulatory compliance and CMC (Chemistry, Manufacturing, and Controls), bringing a wealth of expertise gained from years of dedicated service at the FDA. Now, as a seasoned regulatory consultant, she leverages her insider knowledge and industry insights to guide pharmaceutical companies through the intricate pathways of product development and approval.
With a proven track record of success, she has assisted numerous clients in navigating the complexities of regulatory frameworks to achieve market approval in the US, EU, and Asian markets. Her strategic guidance has propelled countless products from conception to commercialization, ensuring compliance with stringent FDA standards and international regulations.
Drawing upon her deep understanding of facility compliance and CMC requirements, she specializes in optimizing manufacturing processes, streamlining quality control procedures, and mitigating regulatory risks. Whether advising on regulatory strategy, conducting gap analyses, or preparing regulatory submissions, she delivers tailored solutions that empower her clients to overcome regulatory hurdles and achieve their business objectives.
Her commitment to excellence, coupled with a passion for advancing healthcare innovation, drives her to go above and beyond for her clients. As a trusted partner, she is dedicated to facilitating the success of pharmaceutical companies, helping them bring life-changing therapies to patients worldwide.