Life Science

The Pharmaceutical and Medical Device Industry ensures the quality, safety and distribution of medicines/medical equipment. Coengi is involved in the following areas:

• Pharmaceutical
• Biotechnology
• Fine Chemicals
• Cosmetic
• Medical Devices

Expertises :

• Engineering and New Works: Project Management, Revamping, HVAC, Infrastructure, Equipment, Site Monitoring, Specification Management, Drafting of URS
• Industrialization, Qualification and Validation: Production, Installation, Qualification of Equipment/Premises/Utilities/HVAC..., Process Validation (DSP/USP) and Validation of Computerized and Automated Systems
• Quality: Audit, training, analytical methods, system quality assurance, operational, suppliers, quality control and product quality
• Regulatory Affairs: Registration/Submission/Filings of MAs, drafting of variation dossiers, drafting of modules 1 to 5.
• Drafting of technical CE marking files • Quality assurance: system, operational, suppliers, quality control, product quality, audits
• Supply Chain and Project Management: Serialization, Packaging, Continuous Improvement, Lean Manufacturing, Flow Management, Planning, Purchasing, Logistics, Data Management...