Our commitments

Quality Policy

March 20, 2024

BIOPROJET Pharma is a European pharmaceutical laboratory that focuses its activity on clinical and pharmaceutical development, as well as the use and distribution of innovative pharmaceutical products that are pioneers in their therapeutic class (first in class).

To fulfil this mission, BIOPROJET Pharma relies on the skills and expertise of its Research Centre, BIOPROJET Biotech located in Rennes, and its operational departments of Clinical, Medical and Pharmaceutical Development, Regulatory Affairs, Pharmacovigilance, Marketing, Logistics, Quality Assurance, Finance and Human Resources, located in Paris.

Firm in the conviction that a quality policy is a key element in the fulfilment of our missions, we are committed to carrying out our activities as MA Holder and operator in full respect of applicable regulations in line with a continuous improvement process, undertaking to:

Work for the Proper Use of Drugs in compliance with the Code of Public Health;

Apply the standards of the various sets of Best Practices (Clinical, Manufacturing, Distribution, Pharmacovigilance, Promotional Information) and the Code of Public Health;

Listen and respond to the expectations of healthcare professionals, patient associations and patients themselves;

Respond to requests for scientific, medical, or pharmaceutical information from healthcare professionals is a non-proactive and non-promotional manner with no promotional interactions whatsoever.

Make the quality, efficacy and safety of our products a major responsibility for management and all staff;

Take on quality objectives and quality and performance indicators as criteria for company excellence and management;

Communicate our quality objectives to all staff and deploy them in all relevant company roles so that everyone is involved in the process;

Raise awareness and train all staff on the stakes and impact of their work on the quality and performance of BIOPROJET Pharma business activities.

With regard to information activities via solicitation or market research aimed at the promotion of medicines created by or on behalf of BIOPROJET Pharma, BIOPROJET Pharma undertakes to apply the principles of the Charter signed between the Economic Committee for Health Products and Pharmaceutical Companies, specifically by submitting our organisation to the certification procedure according to the associated standard under the control of the Haute Autorité de Santé [French Healthcare Authority]. Our Quality Objectives in terms of promotional information are as follows :

Fostering the proper use of drugs by delivering as complete and objective information as possible to healthcare professionals, in full respect of the charter and the certification standard for soliciting or market research information with a view to promoting drugs;

Guaranteeing the scientific, medical and economic quality of documents presented or delivered to healthcare professionals and those used by the company and its subcontractors to train and assess individuals carrying out promotional information activities;

Ensuring transparent, fair and quality communication on our products in the context of local regulations, ethical rules and best practices for maintenance of the certification;

Developing the scientific and medical skills of individuals responsible for promotional information through suitable integration and continuous training;

Overseeing the quality of our promotional information service providers in a process of continuous improvement;

Taking into account feedback from healthcare professionals to improve their satisfaction;

Raise awareness of promotional information activities across all of the company’s sectors.

Having formed a network of partnerships that is important in the context of subcontracting activities or service provision, we disseminate and apply the principles of our Quality Policy in the monitoring of these subcontracted activities.

Together, we undertake to assign the human, technical, financial and organizational resources necessary for the implementation of the Quality Policy, which forms part of our commitment as a player in the Healthcare System.

Jeanne Marie LECOMTE – CEO and Qualified Person | Jean Guillaume LECOMTE – Managing Director | Elise CHAUVEL – Quality & Compliance Manager

& Transparency Commitment

Charter for information activities
via soliciting or market research aimed at the promotion of drugs

    • Bioprojet is committed to a certification process for its drug promotion information activities by Bureau Véritas. Our promotional activities in private clinics and hospitals have been subject to certification according to HAS standards from March 2017.