Experts in technical-regulatory advice for innovative products: Synthetic and biological medicines. Advanced therapies, medical devices (MDR and IVDR), and cosmetics.
Multidisciplinary Team
Thanks to our multidisciplinary team, we are equipped to support any phase of your innovative project.
Specialized and tailored engineering services for the Pharmaceutical, Biotechnological, and Medical Device industries.
Design, development, implementation, and maintenance of quality assurance systems: GxP and ISO.
Regulatory preclinical services: Conducting gap analysis studies and preparing regulatory preclinical plans.
Clinical operations: Design and execution of studies and clinical trials for human and veterinary medicines, medical devices (MDR and IVDR), and dietary supplements.
REGULATORY AFFAIRS – Comprehensive regulatory support for innovative products: Biologic medicines, advanced therapies, small molecules, medical devices (MDR and IVDR), cosmetics, and dietary supplements.
LEGAL – Legal support at any phase of your project.
INVESTMENT FUNDS – Due diligence for biotech and technology projects.
Train in key areas such as advanced therapy medicines, biologics and biotech medical devices, combining theory, practice and industry experience to prepare you for technical and leadership roles.
Our services are tailored to each client. We help you!
Do you need technical-regulatory support for bringing your products to the european market? We are your team.
Do you need technical-regulatory support for the internationalization of your products? We are your team.
CAR-T cells are a type of treatment where a patient’s T cells (a type of immune cell) are modified in the laboratory to bind to cancer cells and destroy them.
Advanced Therapy Medicinal Products are regulated by Regulation (EC) No 1394/2007.
As shown in the latest report published by AseBio, biotech companies continue to remain among the top five positions in terms of R&D investment intensity.
