Design & engineering in the pharma & biotech field
design of factories, manufacturing facilities, laboratories, manufacturing processes in the fields of pharma and biotech, and project management of this type, requires a combination of theoretical knowledge, practical experience and a thorough understanding of the unique principles that characterize these industries.
Understanding customer needs, regulatory and legislative requirements, reflected in, inter alia, the Ministry of Health, FDA and GMP guidelines, is essential to establish a technology facility that will produce a safe and high-quality product that complies with international regulatory standards. At the beginning of each planning project, the relevant design and information products will be forwarded to the client’s co-sponsors and then to the Ministry of Health to get a “green light” to progress.
Design & engineering consulting services in the pharma & biotech field
Conceptual design for new facilities & laboratories
BOD writing and approval by the Ministry of Health
Detailed design for facilities and laboratories
Process & Engineering projects management
GMP and GEP Consulting
Manufacturing processes technologies
Site Master File
FAT and SAT protocols and execution
Manufacturing processes engineering
Validation for utilities, clean rooms, equipment and systems
Validation for software and control systems
Manufacturing process scale-up
Safety and EHS consulting
Manufacturing process and cleaning validation
Projects Management
Preparations towards GMP audit
Staff training for quality, risk, GMP, clean rooms, contamination etc.
Validation for manufacturing, cleaning and sterilization processes
Other pharma and biotech services