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Biologics
 

Biologics can be broadly defined as those medicines produced using a living system or genetically modified organism. They are different from traditional chemical medicines in many ways. Size is one of the most obvious distinctions: the molecules of a biopharmaceutical medicine are much larger, have far more complex spatial structures and are much more diverse (“heterogeneous”) than the chemical molecules which make up classical drugs.

Synergia Bio Sciences assists innovators and manufacturers of biologics and biosimilars in the identification of the regulatory status of their products. Synergia Bio Sciences participates in the writing of appropriate rationales to support product classification, in product-related risk management, and in the elaboration of adapted product development plans (quality procedures, non-clinical testing, performance and/or clinical evaluation, labelling, instruction for use). We provide assistance for the regulatory submissions to Competent Authorities. Our scope of services also includes the necessary interfacing with Competent Authorities whenever necessary.

Our cross-technical team coordinates knowledge and expertise in its internal center of excellence in order to work efficiently with companies developing innovative biologics. Thanks to our close surveillance of the evolution of regulations for biologics, Synergia Bio Sciences has the opportunity to work frequently on new classes of products for which scientists, product developers and regulators collaborate to create an appropriate regulatory framework.

 
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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