GenoSafe® is a full contract research and consulting organization which specializes in evaluating the quality, safety and efficacy of innovative biological products.
We meet our clients’ specific needs by performing custom studies in strict compliance with regulatory requirements.
GenoSafe is a Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) compliant facility.
GenoSafe is eligible for the CIR (research tax credit). Our clients may include the R&D Services performed at GenoSafe in their own research tax credit calculation.
GenoSafe SAS, a French “société par actions simplifiée” (simplified joint-stock company) registered under French law with its principal place of business at 1 rue de l’Internationale, BP40064, 91002 EVRY Cedex, FRANCE.
The company was incorporated in 2003 and has €650,000 in share capital.
The company is entered in the commercial register of Evry under number B 449 932 474.
SIRET company registration number: 449 932 474 000 25.
The financial situation of GenoSafe has been rated “H3+” (very strong) by the “Banque de France”.
Placing our clients (biotechs, pharmaceutical companies and academic organizations) at the core of everything we do is our first priority.
We assist them with customized services all along the development of their product, from the proof of concept (POC) through to market launch.
We provide a continuum of solutions adapted to their specific needs during the different stages of the product development.
Our activities encompass 4 main domains of activities:
- Preclinical development
- Quality Control testing – Product characterization
- Clinical Development – Follow-up of subjects
- Regulatory Affairs Consulting and administration support
We specialize in the evaluation of cellular and gene therapy products and also other types of product such as vaccines, recombinant proteins, monoclonal antibodies, chemical drugs, cosmetics …
Our core offering is based on expertise in complementary scientific fields: molecular biology, immunology and the control and use of viral vectors and cell lines.
We advise and assist our clients in fulfilling their testing needs including the development of techniques that address challenges encountered during product development:
- Development and validation of specific assays and analytical methods
- Samples analysis
Our clients benefit from our strong Quality Assurance policy. When required, studies are performed in compliance with Good Laboratory Practices (GLP).
A management team composed entirely of scientists with complementary backgrounds and experience.
• A personalized approach. Because your project is unique, we will supply you with personalized solutions by designing and performing studies that specifically meet your needs.
• One-to-one support. A single contact person will provide you with support throughout the lifetime of your project. We provide you with the expertise, dialogue and flexibility that are essential for driving your project forward in accordance of the deadlines.
• Experience. Since our launch in 2004 we have acquired a solid experience and a proven track record.
• Continuous innovation. For our company it is essential to propose our clients new and improved assays on a regular basis. Each year we invest significant resources and efforts in developing new solutions. Innovation is driven internally and through collaborative networks.
• Quality is a major feature of our day-to-day activity. Detailed input from our Quality Assurance team allows us operate in accordance with all appropriate regulatory requirements.
• A reliable long-term partner. We are funded by GENETHON and the AFM-Telethon, which makes us a financially stable company capable of providing you with long-term project support.
• We are the European leader in providing services for the evaluation of gene therapy products.