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.
We support you in all regulatory queries
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.