Regulatory affairs

Our Quality System complies with Eur. GMP requirements:

• Fully compliant with European Clinical Trials Directive 2001/20/EC;

• Authorized by AIFA for the GMP of Biological Active Substances till production for clinical phase III;

• GMP certified with several successful GMP inspections from AIFA (Italian Regulatory Agency);

We continually improve the Quality System by regulatory intelligence and routine internal audits.

We provide regulatory support including filing of IMPD/IND dossier for Regulatory Submissions.

Manufacture and Control of pharmaceutical products (active substances) is performed according to license Nr. aAPI-37/2021 issued on December 13th 2021 by the Agenzia Italiana del Farmaco (AIFA) to produce and control biological active substances (MBHX0120 and MBH1309) for clinical phases.  

In addition, according to license Nr. aM – 25/2021, issued on March 18th 2021 by the Agenzia Italiana del Farmaco (AIFA) only controls (by Quality Control) are performed for finished products (Medicines).