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Development, industrialisation, production of (bio)medicines

ISALYS Life Sciences

Consultancy in development, industrialisation and production of (bio)medicines. Present in France, Belgium and New York since 2026.

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Healthcare | Pharmaceutical | Biopharmaceutical

Activity & Mission

Life Sciences

Accelerating therapeutic innovation, securing the quality of treatments.

ISALYS Life Sciences supports laboratories, industrial companies, and CDMOs/CMOs in their strategic and operational projects, at every key stage of development, production, and quality.

Develop

Support the synthesis of the active ingredient and pharmaceutical development.

Secure

Structure regulatory files, qualify equipment and validate processes.

Optimise

Strengthening production, quality control and batch release.

Chemistry | Biology | Analysis | Quality | Processes

Skills and service offerings

A specialist in the healthcare industry, ISALYS Life Sciences supports pharmaceutical and biopharmaceutical laboratories as well as CMO-CDMOs, in human, animal, and dental health, and medical devices.

Our teams of specialist pharmacists and engineers (chemistry, biology, quality, processes, analytics, qualification) operate across five areas:

Development

Industrialization & Production

Operational Performance

Quality Assurance

Regulatory Affairs

Development

Expertise in pharmaceutical development: synthesis of active ingredients, galenic formulation, medical devices. A pragmatic approach that optimises every stage of the cycle.

Industrialization & Production

Industrial relocation, process control, maintenance and quality control, serving the reliability of manufacturing processes.

Operational Performance

Qualifications, new works and supply chain optimisation, in compliance with industrial and regulatory standards.

Quality Assurance

Strengthening of quality systems, supplier audits, analysis of operations: batches at the highest level of quality.

Regulatory Affairs

Drafting and updating regulatory files, preparation for inspections, and management of non-conformities.

Ambition 2030

By 2030, ISALYS Life Sciences will bring together 175 collaborators specialising in the pharmaceutical industry, present in France, Belgium, the United States and Switzerland. A collective committed to bringing comfort and hope to patients, working on the quality of today's medicines and the therapies of tomorrow.

They trust us

Project references

Project Manager — Princeps Development

Steering the pharmaceutical development of 2 medicines (combination of 2 active ingredients · inhaled medicine with device), including the drafting of analytical methods, protocols, and validation reports.

Qualification & validation — new biomedicines line

Packaging-content interaction & development of a paediatric medicine

Project Manager — Princeps Development

Qualification & validation — new biomedicines line

Coordination of all qualification and validation stages for an aseptic filling unit: utilities, computerised systems, equipment, and APS (Aseptic Process Simulation) testing.

Packaging-content interaction & development of a paediatric medicine

Support for a start-up with an extractables and leachables dossier, in preparation for a regulatory filing (clinical phase 3). Audit, action plan and pre-study on leachables.