Aeronautics, Space & Defence (ASD)
Aeronautics, space systems, defence
Supporting pharmaceutical and medical device projects through thorough expertise in engineering and regulation.
Life Sciences.
Industry overview
The Life Sciences sector (pharmaceuticals, biotechnology, medical devices…) operates in a highly regulated environment, with strict requirements in terms of quality, traceability and product safety.
Between new product development, industrialisation and regulatory compliance, industry players must master their entire value chain. In this context, Coengi supports its clients on engineering, validation and performance projects, integrating the standards of the sector.
Our expertise
Engineering & projects
- Project management (CAPEX, new equipment, expansions)
- Infrastructure design and fit-out (GMP regulatory compliance, clean rooms)
- HVAC and utilities (purified water, clean steam)
- Production equipment integration
- Site supervision and coordination
- Specification writing (URS, FS, DS)
Qualification & validation
- Equipment, utilities and facility qualification (IQ / OQ / PQ)
- Process validation (DSP / USP)
- Computerised system validation (CSV)
- Commissioning & qualification
- Protocol and report writing
- GMP / BPF regulatory compliance
Quality & compliance
- Quality assurance (system and operational)
- Quality control and analytical methods
- Internal and supplier audits
- Deviation management, CAPA and change control
- Regulatory compliance and documentation
- Product quality monitoring
Regulatory affairs
- Marketing authorisation files (MAA)
- Variation writing and management
- Regulatory module writing (CTD)
- Technical files (CE marking for medical devices)
- Regulatory watch
Supply chain & production
- Serialisation and traceability
- Packaging
- Planning and flow management
- Continuous improvement / lean manufacturing
- Procurement and logistics
- Data management
Ready to start your next industrial project?
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Interested in projects in the life sciences sector?
We are looking for engineers specialised in this field.