Michael Koivula's Contact Details

Michael Koivula's Company Details

Allotrope CGMP Consulting

Plymouth Township, Michigan, United States • 1 Employees
Pharmaceuticals

Allotrope CGMP Consulting provides a unique combination of experience and technical expertise for pharmaceutical, biotechnology, and advanced therapy medicines companies.Provides technical scientific consulting services for development, preclinical (GLP), clinical and commercial GMP drug product manufacturing, including inspection readiness, CMC regulatory application support, quality system review and assessment, process and product review including analytical test methods, product stability, deviations, and investigations.Expertise in CGMP Quality Systems and Quality Control laboratory operations, including data governance and data integrity, laboratory controls, standard operating procedures, OOS investigations, instrument qualification, analyst training, test method qualification, validation, transfer, contract laboratory auditing, and regulatory remediation.