Our Business Areas
We provide our clients with technical expertise, operational support and project management.
Life Sciences
Services
Product development
Galenical formulation
Products
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
CRAs
Clinical trial management
Biostatistics
Data Management
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)
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
Health product submission strategy
Regulatory Technology: CMC, Dossier Writing (module 3), Variations
Pharmaceutical Vigilance
Supply chain management
Purchasing
HSE
Document control
Project Management / PMO
Cost Control
Planning
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Process Industry
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