Nicholas Markel headshot

Nicholas Markel

Pharmaceuticals and Dietary Supplements Consulting

North America

Nicholas Markel has 25 years of experience in the biopharmaceutical field and 15 years of experience providing general and strategic consultation to domestic and foreign clients in the biotech, biologic and pharmaceutical industries assisting with manufacturing issues, development of quality systems and regulatory strategies.

Mr. Markel’s areas of expertise include techniques used in biopharmaceutical production for human use, review and development of quality systems, conducting cGMP compliance audits, deviation investigation, CAPA generation and implementation, oversight of manufacturing contractors and manufacturing activities, overall project management, commissioning of new and revised facilities, process validation, man-in-the-plant services to oversee operations and compliance.

Earlier in his career, Mr. Markel worked for Quintiles, Polaris Compliance Consultants and Becker & Associates Consulting.