About Us
Innovative consulting for pharmaceutical, biopharmaceutical, and medical device companies
Nathan Parker (Principal Consultant) has 26 years of progressive experience in the pharmaceutical industry including operations, technical support and quality assurance management culminating in executive leadership roles (VP Manufacturing, VP Quality, Site Head of Quality). Utilizing his strong technical foundation as a Chemical Engineer, Nathan has supported chemical API, biologic drug substance, cell therapy, medical device, drug product, and combination product manufacturing operations (21CFR 210, 211, 820, 600 and 610; ISO13485; IS09001). In his leadership of manufacturing and quality, he has been able to improve the efficiency and compliance within the organizations he has led. Key accomplishments include: support of numerous successful regulatory inspections (FDA, EMA, TGA, Russia, Korea, Ukraine, Turkey, ANVISA), establishing efficient systems to comply with computerized system requirements (21CFR Part 11 and Annex 11), establishing holistic bioburden and contamination control strategies, reorganizing operations and quality organizations to improve effectiveness and efficiency, and implementing systems and training to improve investigations and on-time completion of deviation reports and corrective and preventive actions.