San Juan, Puerto Rico – Prominently featured in The Inner Circle, Melvin Colón is recognized as a Pinnacle Professional Member Inner Circle of Excellence for his contributions to Global FDA Pharmaceutical Consulting.
Melvin Colón has established himself as a distinguished professional in pharmaceutical consulting. Since 2002, he has served as a Senior QA Consultant at MCD Consulting Services.
With over twenty years of industry experience, Mr. Colón provides expert regulatory guidance to clients worldwide, helping them navigate the complexities of bringing new medical products to market.
Mr. Colón is a licensed chemist with a proven track record of success across the pharmaceutical, biotechnology, including cell and gene therapy and biosimilars, and medical device industries, including combination products. His expertise includes Quality Assurance Management, Quality Control, Quality Systems (such as CAPA and Change Control), Validation, Regulatory Compliance, Risk Assessments, Manufacturing Operations, Project Management, OOS and OOTs, Documentation Control, Sterility Assurance, Cleaning Validation, Electronic Batch Records, and internal and external audits of CMO and supplier facilities Additionally, he has extensive experience in remediation activities related to Consent Decrees and sites with regulatory observations (Warning Letters and 483s).
In his current role, Mr. Colón has played a key part in advising a vaccine manufacturer in Mexico, where his sharp eye for regulatory details uncovered significant process gaps. His ability to suggest effective solutions has helped his clients succeed during inspections. His international experience includes collaborations with pharmaceutical companies in Brazil, Iceland, China, Korea, India, the United States, and other markets worldwide. He was part of a leadership team that transformed a clinical site into a commercial facility, earning the first GMP certification and FDA approval for commercial cell and gene therapy products in the USA.
Mr. Colón earned a Bachelor of Science in industrial chemistry from the University of Puerto Rico in 1997. He later obtained a master’s degree in engineering management from the Polytechnic University of Puerto Rico in 2000, followed by a Master of Science in manufacturing competitiveness in 2010.
Throughout his career, Mr. Colón has held senior QA and compliance roles with many organizations, including The FDA Group, The Henrici Group, LST Consulting USA, Pharma BioServ, and others. His early success as a consultant earned recognition from numerous clients and several performance awards.
Outside of his professional pursuits, Mr. Colón is a dedicated husband and passionate dog lover who shares his home with 12 dogs. He enjoys traveling and immersing himself in different cultures, both for work and leisure.
Looking ahead, Mr. Colón remains committed to ensuring that companies around the world are thoroughly prepared for regulatory inspections. His work plays a critical role in helping life-saving medical innovations reach the patients who need them.
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