Allotrope CGMP Consulting

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.

Website

http://www.allotropeconsulting.com

External link for Allotrope CGMP Consulting

Industry

Pharmaceutical Manufacturing

Company size

1 employee

Headquarters

Ann Arbor, Michigan

Type

Self-Owned

Founded

2015

Specialties

methods validation, quality system, quality management system, audit, risk management, equipment qualification, laboratory operations, OOS, supplier qualification, material qualification, drug product manufacturing, cGMP, cleaning validation, process validation, stability, compendial, ICH, FDA, training, and remediation