A French consulting firm specialising in quality management and GxP compliance, expert in pharmaceutical interim management, seeks outsourcing agreements in the pharmaceutical, chemistry, cosmetics, medical devices, biotechnology, CRO and health areas

Summary

Profile Type

Business Offer

POD Reference

BOFR20250623016

Term of Validity

26 June 2025 - 26 June 2026

Company's Country

France

Type of partnership

Outsourcing agreement

Targeted Countries

All countries

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General information

Short Summary

A France-based pharma health and life sciences consulting expert firm is offering quality management services, GxP compliance (audits GxP, training GMP, inspections ANSM/FDA, injunctions, bio-decontamination of ZACs). The company is a leader in transition management in the pharmaceutical / health sector. Cooperation based on an outsourcing agreement.

Full Description

This French firm specializing in quality management and GxP compliance, is the leading provider of interim management services in the Life Sciences sectors : pharmaceuticals, biotechnology, medical devices, cosmetics, chemistry, clinical research, and healthcare facilities (hospitals, clinics, medical analysis laboratories).

Regardless of the company’s size, the French company can intervene at different levels : transition management, management of strategic projects, crisis management to follow up on an order, change management relating to Quality and GxP compliance processes.

It offers a highly responsive service offering, available in less than 24 hours, focused on five areas :
- transition management in the areas of Quality Management Systems,
- GxP compliance,
- regulatory affairs,
- pharmacovigilance,
- clinical research

Securing the clients' business : carrying out GxP compliance projects to guarantee high quality products that are pure, efficacious,and not harmful to patients.
Putting in place personalised systems for Electronic Document Management (EDM) and Electronic Batch Records (EBR).
Deploying personalised digital solutions to remotely manage inspections and audits.
Putting in place monitoring management systems and fill volume control systems.

Provision of specialized interim managers (quality, production, regulatory affairs, etc.)

Audit management, regulatory training and inspections (GMP, GMP, etc.)

Implementation of electronic quality systems and support for ISO 9001 / ICH Q10 certification

Lifting injunctions, ensuring compliance, and maintaining operations

Bio-decontamination, sterilization and ZAC (controlled atmosphere zones) solutions

***High specificity in the creation of Laboratories subsidiaries (pharmaceutical / chemistry...) :
1. Prepare the documents required to open a pharmaceutical establishment Prepare the documents required to open a pharmaceutical establishment (A.O.E)
2. Submit the A.O.E file to the ANSM / FDA
3. Prepare the marketing authorization file (A.M.M)
4. Implement the fundamentals of GMP
5. Implement a quality management system

The French firm's solutions are designed for companies facing managerial emergencies, certification audits, unannounced inspections, quality crisis situations and the creation of subsidiaries in the healthcare industry. Thanks to a proven network of 3,000 experts with over 10 years of experience, the French company operates in France and internationally, using flexible methods and recognized expertise.

The French company favors outsourcing contracts to build strong local partnerships capable of :
- promoting its services in targeted countries
- quickly identifying local needs in terms of GxP compliance and quality emergencies or site creation
- facilitating exchanges with local companies by providing cultural and operational support

This cooperation will strengthen the presence in strategic markets while adapting the clients' approach to local specificities.
The objective is to create a shared growth model based on excellence, trust, and responsiveness.

Advantages and Innovations

The French company stands out for its innovative and agile offering, designed to meet the critical challenges of GxP compliance and business continuity in the Life Sciences industry. Unlike most GxP consulting or interim management firms, it combines :
- Exceptional responsiveness : provision of an expert or interim manager within 24 hours, anywhere in the world.
- Ultra-specialized expertise : a unique network of 3,000 experienced professionals, each selected for their mastery of GxP standards, regulatory inspections, and quality issues in sensitive contexts (pharmaceuticals, biotech, medical devices...).
- Comprehensive operational solutions : beyond consulting, the French firm deploys teams in the field, capable of immediately responding to GxP audits, compliance restoration, biodecontamination, implementation of its digital solutions, and securing critical workflows.
- Contractual flexibility : a flexible offering, from one-off support to complex project management or organizational transformation.

The French firm's competitors often offer more rigid approaches, longer lead times, or expertise less focused on emergency situations. Conversely, it establishes itself as a trusted partner, capable of ensuring compliance, limiting regulatory risks, and ensuring seamless continuity.

Finally, the French company's local partnership approach via an outsourcing contract allows it to precisely adapt to the specific needs of each target country, strengthening its European and global network while offering robust, simple and consistent quality standards.

It is therefore a strategic ally for any international partner wishing to offer high-value, differentiated, and results-oriented services in the Life Sciences sector.

Technical Specification or Expertise Sought

*Simplification of Quality Management Systems (QMS)
- Quality assurance
- Quality control
- Sterility assurance
- Data Integrity
- Inspections/Audits
- Management of ANSM, FDA, and ANVISA orders
- Qualifications - Validations
- Training GxP

*Simplification of the Regulatory Affairs Management System :
- Dossiers for authorisations to open a pharmaceutical establishment
- Marketing authorisation dossiers, etc.

*Simplification of Pharmacovigilance Management Systems :
- Gap analysis of QMS with respect to good pharmacovigilance
- Practices
- Process mapping and continuous improvement, etc.
- Implementation of electronic quality management systems (EDM, EBR, eCRF, etc.)

*Simplification of Management systems for Phase I, II, and III clinical trials
Putting the patient at the heart of all of the clients' processes and business DNA is made up of 6 core values :
- Trust between all parties,
- Employee involvement,
- Patient safety,
- Team responsibility,
- Process simplification,
- Satisfaction with results

*Handling the clients' emergencies :
- Bringing on board Transition Managers in 24 hours.
- Piloting quality projects and proposing a quality plan to follow up on an inspection or a self-inspection.
- Managing crises that arise from orders so as to lift the order and continue manufacturing, certification,free up batches and market products again.

*Simplifying the clients' processes :
- Taking charge of change management in order to refine or improve the QMS and the GxP.
- Correcting gaps identified during inspections and/or internal audits.
- Deploying a training and authorisation system for the employees of the French firm's clients.

Stage of Development

Already on the market

Sustainable Development Goals

Goal 4: Quality Education
Goal 3: Good Health and Well-being
Goal 9: Industry, Innovation and Infrastructure
Goal 13: Climate Action
Goal 17: Partnerships to achieve the Goal

IPR status

Secret know-how

Partner Sought

Expected Role of a Partner

The French firm is seeking clients and strategic partners all over the world with in-depth knowledge of the following sectors :
- Pharmaceutical Industry
- Fine and Industrial Chemicals
- Regulated Cosmetics
- Medical Devices
- Biotechnology
- Clinical Research
- Healthcare (hospitals, clinics, medical analysis laboratories, care centers)

The type of partner sought are organizations or professional stakeholders active in :
- The manufacturing of drugs, active ingredients, medical devices, and all healthcare products
- Quality/regulatory consulting in the Life Sciences
- B2B networking or sales prospecting specializing in the pharmaceutical and healthcare industries
- Recruitment or placement of qualified talent (CoDir members, quality experts, compliance managers, GxP consultants)
- Health/pharmaceutical clusters, hubs, or incubators with a mission to support industrial development
- Sales representative firms, brokers or distributors of specialized services

Expected role of the partner :
- Identify and qualify new leads in target industries at the local or regional level
- Act as a sales representative to promote the French firm's services (transition management, GxP compliance, GMP audits, FDA and ANSM inspections, biodecontamination)
- Support networking with key decision-makers (Quality Management, Operations Management, General Management, Site Management, etc.)
- Offer support for local contracting if necessary
- Provide an understanding of the local regulatory and cultural context
- Participate in joint value creation by integrating the French firm's offering into a comprehensive continuous improvement or crisis management approach for its clients

The ideal partner is :
- A player willing to establish a subsidiary abroad in the pharmaceutical, chemistry and Life sciences
- A locally established player with an active and credible network in the life sciences industry
- Capable of detecting high-stakes situations : quality emergencies, audits, unplanned departures and injunction lifting
- Experienced in B2B relationships with demanding clients (Big Pharma, biotech startups, hospitals, CDMOs, etc.)
- Endowed with an entrepreneurial, results-oriented spirit, with a commitment to long-term co-development
- Capable of promoting a premium, agile, and highly specialized offering, such as the French firm's expertise and innovative cleanroom decontamination solutions, its EDM and eQMS

Type and Size of Partner