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Advanced Therapy Medicinal Products (ATMPs)

Advanced Therapy Medicinal Products (ATMPs) are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burn victims, Alzheimer, cancer or muscular dystrophy. They have a huge potential for patients and industry.

The lack of an EU-wide regulatory framework in the past led to divergent national approaches which hindered patients’ access to products, hampered the growth of this emerging industry, and ultimately affected the EU competitiveness in a key biotechnology area.

Synergia Bio Sciences provides companies developing ATMPs support and guidance on the optimal registration pathway and clarification of the regulatory status of their product. This includes helping client companies determine optimized regulatory strategies and prepare development plans using the Risk Management approach as recommended by the European Medicines Agency guidelines. Synergia Bio Sciences’ services also include assistance in the identification of indications that may be targeted and the type of preclinical and clinical studies to conduct.

Synergia Bio Sciences provides support for the registration process of ATMPs in Europe and emphasizes interaction and communication with the regulatory agencies during the registration period to find the best match between the data to be generated and the EU requirements.

Synergia Bio Sciences delivers:
Determination of regulatory strategy
Determination of regulatory status for biologics, and writing of appropriate rationales
IProduct related risk management
Data review and recommendations on development plan, and its implementation
Focus on specific testing to perform with combination products
Program management for the implementation of clinical trials protocol and CRF design, regulatory submissions, investigator identification
Close monitoring of pilot studies
Liaison between sponsors, Notified Bodies and Competent Authorities
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