Agustín Azcatl Romero
Counsel
Pharmaceutical Industry, Regulatory Affairs & Intellectual Property Specialist
Pharmaceutical Chemist (QFB) with over 34 years of experience in the pharmaceutical industry, specializing in process validation (aseptic and non-aseptic), critical systems, quality assurance, regulatory affairs, and intellectual property. Extensive background in supervising critical production systems, ensuring national and international regulatory compliance, and developing strategies for the protection of intellectual assets related to pharmaceutical and biotechnological products.
Proven expertise in validation project management, risk assessment, regulatory authority liaison, and specialized technical advisory, as well as in the drafting, prosecution, and defense of patent applications, utility models, and industrial designs, including prior art searches and technical infringement opinions.
His professional profile integrates strong technical expertise, regulatory knowledge, and leadership capabilities, with a strategic focus on continuous improvement and the development of effective solutions to complex challenges within the pharmaceutical and healthcare sectors.
Active member of leading national and international professional associations in the pharmaceutical and intellectual property sectors. Currently serving as President of the National Association of Pharmaceutical Chemists and Biologists of Mexico (CNQFB), with a solid track record of leadership roles within professional councils.
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