Services
Our professional experience and technical strengths include the following:
- Pharma / Bio consulting
- Functional programming
- Scope development
- Process engineering
- Preparation of process flow diagrams
- Process equipment selection and integration
- Preparation of general arrangement drawings
- Development of circulation strategies
- Preparation of P& IDs
- Process analysis and optimization
- Process and facility automation
- Facility design
- Clean utilities design
- HAZOP reviews
- cGMP audits
- Construction supervision and management
- Preparation of equipment pre-purchase packages
- Procurement and follow-up
- Start-up assistance, debugging and commissioning
- Validation (FDA, HPB and EEC)
- Validation master plan (VMP)
- Installation qualification (IQ)
- Operation qualification (OQ)
- Performance qualification (PQ)
- Process validation (PV)
- Cleaning validation
- Standard operating procedure (SOP) writing
- cGMP training
- Compliance audit
- Computer programming and validation complying with 21 CFR part 11 (FDA-USA)
- SCADA
- PLC