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.
Company Details
- Founded
- -
- Address
- Ann Arbor, Michigan 48208, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- allotropeconsulting.com
- Keywords
- 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, remediation.
- HQ
- Ann Arbor, Michigan
Allotrope Cgmp Consulting Questions
Allotrope Cgmp Consulting's website is allotropeconsulting.com
Allotrope Cgmp Consulting's LinkedIn profile is https://www.linkedin.com/company/allotrope-consulting
Allotrope Cgmp Consulting's industry is
Pharmaceutical Manufacturing
Allotrope Cgmp Consulting's top competitors are
Supplyfirst,
Cgmp Consulting Inc.,
Catalent,
Ancient Traditions,
Naerobix,
Life Science Professionals, Llc,
Negotiumbio,
Dynacompliance Pvt Ltd,
Drug Discovery Alliances, Inc.,
Great Causes.
Allotrope Cgmp Consulting's categories are Pharmaceutical Manufacturing
Allotrope Cgmp Consulting's founding year is 2015
