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Meeting your GMP requirements is our top priority

FDA cGMP, EU GMP, Inspections, GMP Audits and more...

Quality assurance and regulatory support

As a partner to pharmaceutical, biotechnology, and chemical companies, quality is the center of ChemCon’s activities. All services are performed following or exceeding all current rules and regulations for the protection of health, safety, and environment.

Quality policy for ChemCon’s GMP products

ChemCon GmbH commits that all batches with a Certificate of Compliance issued and produced at its facilities in Germany are manufactured in accordance with current Good Manufacturing Practices as set forth in 21 CFR Parts 210, 211 and ICH Q7.

Every employee receives training in current Good Manufacturing Practice (cGMP) and standard operating procedures (SOPs). Internal routine audits and external inspections assure that our quality systems are consistent with current GMP industry standards at all times. Our independent quality assurance department reviews all data and procedures. The review process also includes effectiveness of corrective and preventative actions (CAPA).

Inspections and audits - see for yourselves

We support you in all regulatory queries

Regulatory support

ChemCon’s regulatory affairs team offers individual and comprehensive support for all regulatory queries regarding your project.

This ensures that you project fulfills all regulatory requirements: from the choice and qualification of a starting material supplier, via manufacturing, validation, quality control and release, all the way to compliant shipping.

Your GMP product will be accompanied by comprehensive CMC-section documentation for the submission of international dossiers. ChemCon holds eCTD software and can offer to support the filing of your dossiers or to carry out the submission of international dossiers for you.