Life Sciences

Our Business Areas

We provide our clients with technical assistance, operational support and project management services.

Our areas of expertise

Recherche et développement

Research and Development

  • Product development

  • Galenical formulation

  • Products

etude technique

Technical Research

Technical Skills :

  • Processes: equipment, piping, mechanics

  • EIA : Electricity Instrumentation Automation

  • Studies: dimensioning & technical design.

Assignments :

  • Technical specifications: URS / FS / DS

  • Deployment Serialization / Aggregation

  • Product Industrialisation

  • Process development

etudes cliniques

Clinical trials

  • CRAs

  • Clinical trial management

  • Biostatistics

  • Data Management

démarrage

Launching

  • Supervision of construction work - Site management

  • Qualification / Validation :

    • drafting and execution of test protocols

    • FAT/SAT, IQ, OQ, PQ :

    • Qualification of production equipment

    • Qualification of laboratory equipment

    • Qualification of utilities + sterile rooms

  • IT systems validation (VSI)

  • Process validation (Processes, Cleaning / Sterilisation)

Qualité

Quality

Quality Insurance :

  • System QA

  • Operational QA: investigations, CAPA management, audit planning

Quality control :

  • Development and validation of analytical methods

  • Operational support: QC technicians

  • Management of laboratory transitions

  • Planning and stability management

affaires règlementaires

Regulatory Affairs

  • Health product submission strategy

  • Regulatory Technology: CMC, Dossier Writing (module 3), Variations

  • Pharmaceutical Vigilance

support

Support

  • Supply chain management

  • Purchasing

  • HSE

  • Document control

Gestion de Projets

Project Management

  • Project Management / PMO

  • Cost Control

  • Planning