Commitments and values

Bioprojet is committed to ensuring the quality of its medicines at every stage, from research to market launch. This commitment is based on a rigorous approach rooted in ethics, transparency, and compliance with the highest standards. The proper use of medicines and patient safety remain at the core of all decisions. These values guide the daily work of our teams.

#BIOTECH

Quality policy

February 2025

BIOPROJET Pharma is a European pharmaceutical laboratory focused on clinical and pharmaceutical development, commercialization, and distribution of innovative, first-in-class pharmaceutical products.

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

Convinced that a strong quality approach is a key element in fulfilling our mission, we are committed to conducting our activities as Marketing Authorization Holder and operator in full compliance with applicable regulations and with a continuous improvement approach, to provide effective medicines by :

1

Working to ensure the Proper Use of Medicines in accordance with the Public Health Code

2

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

3

Applying the rules of the various Good Practices (Clinical, Manufacturing, Distribution, Pharmacovigilance, Promotional Information) and the Public Health Code

4

Establishing quality objectives and quality and performance indicators as criteria for excellence and company management

5

Listening and responding to the expectations of healthcare professionals, patient associations, and patients

6

Communicating our quality objectives to all employees and integrating them into all relevant areas of the company so that everyone is involved in the ongoing approach

7

Responding to scientific, medical, or pharmaceutical information requests from healthcare professionals in a non-proactive, non-promotional manner and outside any promotional interaction

8

Raising awareness and training all employees to ensure they understand the stakes and impacts of their activities on the quality and performance of BIOPROJET Pharma’s operations

1

Working to ensure the Proper Use of Medicines in accordance with the Public Health Code

2

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

3

Applying the rules of the various Good Practices (Clinical, Manufacturing, Distribution, Pharmacovigilance, Promotional Information) and the Public Health Code

4

Establishing quality objectives and quality and performance indicators as criteria for excellence and company management

5

Listening and responding to the expectations of healthcare professionals, patient associations, and patients

6

Communicating our quality objectives to all employees and integrating them into all relevant areas of the company so that everyone is involved in the ongoing approach

7

Responding to scientific, medical, or pharmaceutical information requests from healthcare professionals in a non-proactive, non-promotional manner and outside any promotional interaction

8

Raising awareness and training all employees to ensure they understand the stakes and impacts of their activities on the quality and performance of BIOPROJET Pharma’s operations

QUALITY OBJECTIVES

Regarding information activities through canvassing or prospecting aimed at the promotion of medicines carried out by or on behalf of BIOPROJET Pharma, BIOPROJET Pharma undertakes to apply the principles of the Charter concluded between the Economic Committee for Health Products and the Pharmaceutical Companies, in particular by submitting our organization to the certification procedure according to the associated standard under the supervision of the Haute Autorité de Santé.

Our Quality Objectives for promotional information are as follows :

1

Promote the proper use of medicines by providing the most complete and objective information to healthcare professionals, in compliance with the charter and the certification standard for information through canvassing or prospecting aimed at the promotion of medicines

2

Ensure the scientific, medical, and economic quality of the documents presented or provided to healthcare professionals, as well as those used by the company and its subcontractors to train and evaluate the persons carrying out promotional information activities

3

Ensure transparent, fair, and high-quality communication about our products in compliance with local regulations, ethical rules, and good practices to maintain certification

4

Develop the scientific and medical skills of those responsible for promotional information through appropriate onboarding and continuous training

5

Monitor the quality of our promotional information service providers within a process of continuous improvement

6

Take into account feedback from healthcare professionals to improve their satisfaction

7

Raise awareness throughout the company about promotional information activities

1

Promote the proper use of medicines by providing the most complete and objective information to healthcare professionals, in compliance with the charter and the certification standard for information through canvassing or prospecting aimed at the promotion of medicines

2

Ensure the scientific, medical, and economic quality of the documents presented or provided to healthcare professionals, as well as those used by the company and its subcontractors to train and evaluate the persons carrying out promotional information activities

3

Ensure transparent, fair, and high-quality communication about our products in compliance with local regulations, ethical rules, and good practices to maintain certification

4

Develop the scientific and medical skills of those responsible for promotional information through appropriate onboarding and continuous training

5

Monitor the quality of our promotional information service providers within a process of continuous improvement

6

Take into account feedback from healthcare professionals to improve their satisfaction

7

Raise awareness throughout the company about promotional information activities

Having built a significant network of partnerships as part of outsourcing or service provision activities, we disseminate and apply the principles of our Quality Policy in the monitoring of these outsourced activities.

Together, we commit to allocating the human, technical, financial, and organizational resources necessary to implement this Quality Policy, an extension of our commitment as an active participant in the Healthcare System.

Elise CHAUVEL – Group Quality & Compliance Director
Jean-Stéphane JULIEN – Deputy Managing Director, Responsible Pharmacist
Philippe LEROY – Chief Executive Officer

Elise CHAUVEL
Group Quality & Compliance Director

Jean-Stéphane JULIEN
Deputy Managing Director, Responsible Pharmacist

Philippe Leroy
Chief Executive Officer

Ethical Commitment

& transparency

CHARTER FOR INFORMATION ACTIVITIES THROUGH CANVASSING OR PROSPECTING AIMED AT THE PROMOTION OF MEDICINES

1

Bioprojet is engaged in a certification process for its promotional information activity on medicines by Bureau Veritas. Our promotional activities in the community and hospital settings have been certified according to the HAS standard of March 2017.

Promotional Information Certificate 2023

2

Bioprojet is committed to complying with the Charter for Information through Canvassing or Prospecting Aimed at the Promotion of Medicines (Charter of October 15, 2014) and the associated HAS standard published in March 2017.

Promotional Information Charter Certification Standard for Promotional Information – March 2017 Code of Ethics

CORPORATE SOCIAL RESPONSIBILITY

At Bioprojet, an independent and responsible pharmaceutical company, we place Research and Innovation at the heart of our mission. Our goal is to meet unmet medical needs by developing and providing innovative therapies that improve patients’ lives.

Our commitments are based on three fundamental mainstays that embody our values and reflect our DNA :

Providing patients with innovative therapies.
Building trust-based relationships with our employees.
Integrating environmental considerations into our decision-making.

These mainstays form the foundation of our Corporate Social Responsibility (CSR) approach, highlighting our commitment to sustainable, ethical, and responsible development.

Our commitments

1. PROVIDING INNOVATIVE THERAPIES TO PATIENTS

Bioprojet prioritizes the development and availability of first-in-class products. This commitment is demonstrated through:

Prioritizing unmet medical needs: We are dedicated to developing innovative therapeutic solutions to address unmet medical needs.
Facilitating access to care: Making our various treatments accessible to as many patients as possible.
Ensuring a reliable supply of medicines: We guarantee the continuous availability of our products, in compliance with the highest quality and safety standards.

This mainstay reflects Bioprojet’s deep belief in innovation and its commitment to providing effective treatments with a favorable benefit–risk ratio for the greatest number of patients.

2. CULTIVATING TRUST-BASED RELATIONSHIPS WITH OUR EMPLOYEES

At Bioprojet, we promote a culture of trust and care, rooted in our family values. This mainstay reflects our commitment to :

Recruiting and developing talent: We offer our employees continuous training, development opportunities, and professional fulfillment.
A fulfilling work environment: We are committed to creating a work environment where every employee can fully thrive.
Transparency and responsible communication: We foster an atmosphere of trust by ensuring clear, open, and transparent communication with our employees, partners, and stakeholders.

This mainstay reflects our determination to promote trust, kindness, and mutual respect throughout our value chain, putting people at the heart of our actions.

3. INTEGRATING ENVIRONMENTAL CONSIDERATIONS INTO OUR DECISIONS

Aware of our impact on the environment, we are committed to adopting a responsible and proactive approach to minimize our ecological footprint. This responsibility is expressed through:

Continuous optimization of our operations : We implement environmentally friendly practices to reduce our greenhouse gas emissions and optimize our resource use.
Engaging our employees and partners : We raise awareness among our teams and partners about the importance of sustainable development, encouraging collective commitment to protecting our planet.
Sustainable practices : We integrate eco-design, resource and waste management throughout our value chain, favoring ecological and responsible solutions.

This mainstay demonstrates our determination to contribute to a fairer and more sustainable future by actively protecting the environment and reducing our carbon footprint.

IMPLEMENTATION AND MONITORING

To ensure these commitments are realized, Bioprojet has established :

Ongoing dialogue with all stakeholders : Patients, employees, partners, and civil society are involved in our initiatives to align our efforts with their expectations and needs.

CONCLUSION

At Bioprojet, we have made Corporate Social Responsibility (CSR) a central strategic focus, convinced that today’s actions will positively shape the health and well-being of future generations. Guided by our values of innovation, trust, and responsibility, we aim to be a laboratory that not only serves patients but actively contributes to a more sustainable, fair, and responsible society.

This commitment extends beyond our own organization, as it also involves all our suppliers. We require them to comply with our Supplier CSR Charter, thereby ensuring that every actor in our value chain shares our principles and upholds strict ethical, social, and environmental standards. Together, we work towards a more responsible future, based on collaboration, innovation, and transparency.

Download our Charter

Supplier CSR Charter

To know how to wonder is the first step on the road to discovery.

LOUIS PASTEUR

VALUES CHARTER

Bioprojet’s employees follow a path set by the Founders and are guided in their mission by strong values:

Innovation, integrity, excellence, passion, and commitment in the service of Science & Health for patients.

1

INNOVATION

Our laboratory stands out for the innovative strength of its preclinical research center.

2

INTEGRITY

Our quality charter reflects Bioprojet’s and its employees’ commitment to complying with all the rules and Good Practices inherent to our professions and activities.

3

EXCELLENCE

Our successes are the result of our employees’ excellence and dedication.

4

PASSION & COMMITMENT

Bioprojet is a human-scale company that encourages autonomy and a sense of responsibility, as well as interaction, enabling each employee to fully thrive.

A French laboratory, Bioprojet markets innovative medicines, most of which originate from its research center located in Rennes.