Above and beyond
We pride ourselves on attaining the highest standards of quality and regulatory compliance (EMA and FDA) and are licensed by the Italian Ministry of Health (AIFA) for the manufacture of Phase III clinical supply for human use.
Menarini Biotech’s primary objective is to work effectively and efficiently in partnership with our customers to produce safe, efficacious, quality biologics that ensure a smooth path to market.
We meet the highest levels of compliance with European and FDA regulations and guidelines for the manufacture of therapeutic biopharmaceuticals for clinical use. We are continually improving our quality system with regulatory intelligence and routine internal audits.
We provide this assurance as standard, but strive to give you more. We also share our expert knowledge of regulatory processes and offer support for your applications.
Take advantage of our:
- Full compliance with European Clinical Trials Directive 2001/20/EC and FDA standards
- Authorisation by AIFA (Italian Healthcare Authority) for the cGMP manufacture of Investigational Medicinal Products (IMPs)
- QP release
- Shipment to clinical trial sites
- Provision of regulatory support including assistance in the compilation regulatory submissions
- Support with CMC filings including face-to-face agency meetings
- Representation at AIFA and FDA meetings to support programmes
- Process and facility validation advice services
- GxP consultancy
- Validation package (IND, IMPD, BLA)
Get in touch to benefit from our expertise and experience today