Advanced Therapy
Staying up to date on regulatory issues and official procedures is key when developing Advanced Therapies. Gene therapy, as well as cell therapy and tissue engineering, represent groundbreaking techniques in health care and clinical research industries.
The Advanced therapy medicinal products (ATMPs) encompasses an innovative and heterogeneous group of products. The source of the raw Materia, the manufacturing process, the designs of the clinical trials, the pharmacovigilance, the authorization process… they all have a complex diversity. In addition, if ATMPs contain genetically modified organisms (GMO), the legislation on the deliberate release of the GMO in the environment must be applied.
Sermes CRO’s qualified team has achieved outstanding results when dealing with ATMPs, as we have taken part in the clinical development and authorization process of the first Advance Therapy Medicinal Product authorization in Spain (that took place in 2019).
Activities
Clinical Consultancy
Being at the forefront of rapidly changing clinical and regulatory developments is our day-to-day work. We have taken part on several ATMPs studies: CAR-T cell-based antitumor therapy, critical ischemia with diabetes, liver regeneration, cardiology, graft versus host and spinal injuries.
- Advanced Therapy product classification.
- Scientific advice on submission to Regulatory Authorities.
- Advanced Therapy Medicinal Products regulation.
- CTD (Common Technical Dossier) elaboration, in order to get the
authorization for non-commercial ATMP (following RD 244/2014).
GMOs Specialists
We can help you make clear, confident decisions regarding your Genetically Modified Organisms regulatory issues and overcome the obstacles that can slow down your clinical trials and paperwork. European requirements can be extremely different between countries, as regulations have not been harmonized yet. Along with the fact that GMO releasing usually require additional documentation to be submitted and authorized.
- GMO authorization request and GMO clinical trials follow-up.
- Pre-authorization GMO clinical trials services. (Authorization requirements consultancy, both for sponsors and sites).
In collaboration With
Certifications:
