GeneSphere
Biopharma
Turnkey Project Services -
1. Concept and planning: Feasibility studies, concept planning, and developing project schedules and cost estimates.
2. Design and engineering: Architectural and engineering design, plant layout, man and material movement drawings, and HVAC and clean-room system design.
3. Infrastructure and utilities: Designing and integrating utilities (civil, electrical, mechanical) and environmental and safety engineering.
4. Equipment and installation: Sourcing, procuring, and installing all necessary manufacturing and lab equipment.
5. Commissioning and validation: Handling qualification activities (DQ, IQ, OQ, PQ) and process validation to ensure the facility operates as intended.
6. Regulatory compliance: Providing documentation and support to ensure the facility is ready for regulatory audits and meets standards like GMP, USFDA, and WHO-GMP.
