COMPLIANCE AND LIFE SCIENCES ENGINEERING
Our experts will support you in meeting compliance and engineering requirements and new technological challenges.
The life sciences sector is in constant transformation. New opportunities are opening up due to the convergence of scientific innovation, new technologies and new ways of marketing.
These advances are beneficial to patients and the care they receive, but they also bring new challenges that need to be addressed.
At Seres we help you to anticipate these changes by providing support on compliance and engineering. We work with you to address emerging risks such as technological revolutions, increased competition and new regulations. We provide you with comprehensive solutions from design to certification to market launch. Finally, we help you to anticipate future changes and increase your industrial performance to be the major players in your sector.
Our offer
Our team of specialists offers a response adapted to the specific nature of the requests to provide "tailor-made" solutions.
Compliance and Quality Assurance
Operational assistance in bringing your facilities into compliance. Our teams are fully committed to meeting the requirements of your industry. We offer our skills and expertise to your company in many sectors with high regulatory challenges:
- Quality assurance and control : Deviations, CAPA, change control.
- Management of regulatory affairs (drafting and proofreading of compliance files).
- HSE (Health, Safety and Environment) and industrial risks.
- Implementation of action plans and support in the transformation phase (training, coordination).
Design and development of your medical devices
Our experts offer you full support in the development of your medical devices (MD). We cover the main disciplines from product design to the acquisition of certifications / regulations (CE marking, labelling, DMF, PMA). Our method involves the following stages: studies, design control, DM tests, supplier tests (FAT / SAT support), validation, qualification protocols (IQ / QQ / PQ), commissioning plan.
Operational Excellence in the Health Sector
We have the capacity to support you in all areas of operational excellence and product performance:
- Performance of processes and organisations:
Audit, diagnosis, improvement or transformation plans, transition management, procurement management - Industrial Performance & Project Management :
Performance optimization, industrialization management, cost optimization, supply chain, PMO, etc. - Studies (throughout the V-cycle), specifications and designs.
- Commissioning, qualification and validation.
- Maintenance engineering.
- Site supervision, construction.
our added value
- Multiple and complementary skills
- A team of experts including doctors, biologists and engineers who develop their skills in the pharmaceutical, medical device and cosmetics sectors.
- Technical departments (engineering, regulatory, quality, ergonomics, etc.).
- Regular emulation between our teams, with the objective of cross-disciplinary expertise.
- Presence throughout France and Europe.
Our offer
Our team of specialists offers a response adapted to the specific nature of the requests to provide "tailor-made" solutions.
Compliance and Quality Assurance
Operational assistance in bringing your facilities into compliance. Our teams are fully committed to meeting the requirements of your industry. We offer our skills and expertise to your company in a wide range of sectors with high regulatory challenges:
- Quality assurance and control : Deviations, CAPA, change control.
- Management of regulatory affairs (drafting and proofreading of compliance files).
- HSE (Health, Safety and Environment) and industrial risks.
- Implementation of action plans and support in the transformation phase (training, coordination).
Operational Excellence in the Health Sector
We have the capacity to support you in all areas of operational excellence and product performance:
- Performance of processes and organisations: Audit, diagnosis, improvement or transformation plans, transition management, procurement management
- Industrial Performance & Project Management : Performance optimisation, industrialisation management, cost optimisation, supply chain, PMO, etc.
- Studies (throughout the V-cycle), specifications and design.
- Commissioning : qualification and validation.
- Maintenance engineering.
- Site supervision, construction.
Design and development of your medical devices
Our experts offer you full support in the development of your medical devices (MD). We cover the main disciplines from product design to the acquisition of certifications / regulations (CE marking, labelling, DMF, PMA). Our method involves the following stages: studies, design control, tests, supplier tests (FAT / SAT support), validation, qualification protocols (IQ / QQ / PQ), commissioning plan.
Our added value
- Multiple and complementary skills
-
A team of experts including doctors, biologists and engineers who develop their skills in the pharmaceutical, medical device and cosmetic sectors.
- Technical departments (engineering, regulatory, quality, ergonomics, etc.).
- Regular emulation between our teams, with the objective of cross-disciplinary expertise.
- Presence throughout France and Europe.
OUR DIFFERENT SECTORS OF ACTIVITY
Pharmacy
- Medicines
- Parapharmacy
Medical devices (Class I, IIa, IIb, III)
- Instruments
- Implants
- Materials
- Prostheses
- Tests
- Software
Biotechnology
- Red biotechnology (therapeutics)
- White biotechnologies (biofuels)
- Green biotechnology (agriculture)
- Yellow biotechnology (environmental protection)
Cosmetics
- Creams
- Shampoos, shower gel
- Make-up
- Fragrances
- Oils
Agri-food
- Agriculture
- Power supply
- Chemistry
Employee testimonials
Edouard B.
Pharmacist specialising in Regulatory Affairs, Ile de France Agency Manager
The diversity of the health sector industries makes its different professions exciting! Whether it is the pharmaceutical industry (various pharmaceutical forms, from tablets to monoclonal antibodies to monoclonal antibodies and the ranges we all know), or in the Medical Device (MD) industry, the Medical Devices (MD) industry, boredom is impossible! Teamwork is a strong issue, during the challenges in which I have participated over the last 5 years, all the departments had to work together. years, all the departments had to fit together like pieces of a jigsaw puzzle in order to complete the various different projects. Regulatory Affairs - especially in the context of developing biological products - have been a real marker in my professional life, with the desire to discover a little (or a lot) more every day. every day a little (or a lot) more! Joining the Seres Technologies teams was for me a guarantee of serene development (via our technical departments) in a sector that is passionate about our technical departments) in an exciting sector: HEALTH!
DISCOVER ANOTHER SERES BRAND EXPERTISE
In an industry that is constantly changing, where standards and regulations are constantly evolving and where constant monitoring is required, having up-to-date knowledge is a major challenge in terms of competitiveness and regulatory compliance.
