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Quality Control and Regulatory Affairs

Quality Control and Regulatory affairs

Service Scientific Director: Francisco Miguel Sánchez Margallo, PhD.

Service Scientific Coordinator: Jose Francisco Guillen Caro, PhD.

Industrial need covered

Ensuring biomedical and biotechnological solution’s compliance with governmental and European policies and regulations exceeds most organizations  and companies’ expertise.´. Some of the hasslings are: lack of in-house capacity for the development of preclinical and clinical phases, need of specialized capacities/expertise, high quality drug manufacturing documentation for regulatory approval, need to ensure results reliability and that quality standards are met to cover the entire value chain of a drug’s life cycle from drug development, preclinical trials and clinical trials up to product commercialization.

Description

NANBIOSIS advisory services

NANBIOSIS multidisciplinary science background allows us to offer services to pharmaceutical, biotechnological, medical device companies and research organisations from R&D to manufacturing, backing them up with the required scientific know-how, and providing them with solutions in all stages of a new product or medical device development including quality control and regulatory affairs.

Service is mostly provided by JUMISC’s, but, depending on the special characteristics of the product in development, CIBER-BBN and IBIMA- Platafoma Bionand are also involved. 

Services involved:

GLP Services: 

Animal Models: 

Some examples are described:

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