Standards and Certifications
Good Manufacturing Practices, Good Distribution Practices
GMP and GDP ensure the quality of medicines along the production and the distribution chains of pharmaceuticals. Compliance with these good practices of 2001/83/EC directive allows us to provide the patient with a product of quality and helps us ensure the follow-up of the product throughout its lifecycle.
The French National Agency for the Safety of Medicines (ANSM) regularly inspects the good implementation of regulatory standards on site.
The directive 93/42/CE establishes the rules with regard to the conception, manufacturing and post-marketing follow-up of medical devices (MD). This directive is applied through a quality system set by ISO 13485 standards (adapted from ISO 9001 to MD specifics). The implementation of these standards allows our notified organisms to verify compliance to this directive.
The good implementation of these standards is yearly assessed through audits run by certifying bodies.
The ISO 9001 standard specifies the requirements with regard to the quality management system to demonstrate its capacity to regularly provide a product that is compliant with client, legal and regulatory requirements. It also targets increasing client satisfaction by applying an efficient quality system and its continuous improvement. We have chosen to be ISO 9001 certified because we place the satisfaction of our clients at the heart of our business.
A certifying body ensures, on a yearly basis, that our processes are continuously improved and that we respect the standards requirements.
The directive 2002/46/EC is relative to the quality and composition of food supplements. The good implementation of this directive allows us to conceive, manufacture and market food supplements that are compliant with regulatory requirements. The control of our products ensures their quality.
ISO 22716 – Cosmetics
Good manufacturing practices
Regulation 1223/2009 (EC)
The regulation 1223/2009 (EC) relative to cosmetic products establishes the rules that every cosmetic product to be marketed should meet to ensure a high safety level for human health. We implement this regulation jointly with ISO 22716 standards which provides good manufacturing practices guide for cosmetic products to ensure the quality of our products.
The good implementation of ISO 22716 requirements is verified, on a yearly basis, by a certifying body.
The ISO 14001 standard allows socio-economic players to assess their business with respect to the environment, to implement and demonstrate their commitment to protect it. We are firmly committed to improve our environmental performance on a daily basis through the implementation of this standard which ensures that the impact of our business on the environment is controlled.
Compliance with this standard is assessed, on a yearly basis, by a certifying body.
Good Clinical Practices
Good clinical practices define the regulatory frame of biomedical studies performed with medicines. Compliance with these good practices certifies the quality, efficacy and safety of our products.
Compliance with these requirements is verified by the National Agency for the Safety of Medicines (ANSM).
Certification Rules of Medical Representatives (HAS)
Information charter for canvassing or prospecting seeking the promotion of medicinal products
Certification rules of medical representatives define the rules relative to delivered information on medicinal products when canvassing or prospecting healthcare professionals. We are firmly committed to our image and we apply this standard to ensure compliance and deontology of our medical representation practices. The good implementation of these rules is verified, on a yearly basis, by a certifying body.
Dernière mise à jour le : 16/07/2015