cGMP API Manufacturing Services

From risk assessment to cleanroom production, quality underpins everything

Since 2007, HFR has been audited by the MHRA for the manufacture of active pharmaceutical ingredients (APIs) to cGMP standards. We work in accordance with EU guidelines for the manufacture of medicinal products for clinical trials, giving clients complete confidence in both compliance and quality.

cGMP manufacturing in practice
Our cGMP production is conducted in ISO Class 8 clean rooms by dedicated chemists, with full QA oversight. Every project is supported by a robust quality system covering personnel, facilities, equipment, documentation, change control, production and storage. The result is high-quality material, delivered with complete traceability and all required regulatory documentation.

Supporting client success
We know that some early-stage companies have limited cGMP experience. That is why our team provides hands-on guidance throughout all stages of development and manufacture

From inception to clinical trials
With decades of experience in developing and overseeing projects from medicinal chemistry routes to clinical batches, we combine scientific excellence with quality assurance to deliver APIs that advance confidently through development.

Our cGMP capability at a glance

MHRA audited since 2007 for the production of APIs to support clinical trials
Compliant with EU cGMP guidelines for medicinal products
Collaborative approach to risk assessment and cGMP process design
ISO Class 8 clean rooms with dedicated cGMP chemists
Full QA oversight ensuring traceability and compliance
Scientific excellence with quality assurance, delivering high-quality material and regulatory documentation