The Excellence Consultancy
The Excellence Consultancy
The consultancy service sector of Gratia Pharma solution is registered as “The Excellence Consultancy” and offers differentiated consultancy solutions to pharma and biopharma companies with a highly experienced team of professionals having extensive relationship and exposure of pharmaceutical and biopharmaceutical industry for over more than two decades.
Technical capabilities
The Excellence Consultancy and Gratia Pharma Solutions has alliance with of leading technical and GMP experts from various areas of the pharmaceutical sectors. The blend of following experience and expertise makes us One-Stop Consulting solution for you.
- Quality Assurance and Quality Control
- Toxicological studies and GLP
- Cell line development and characterization
- Vaccine development
- Chemical and Microbiological assays
- Computer system validation
- Process development and manufacturing of pharmaceutical APIs
- Process development and manufacturing of biopharmaceutical APIs
- Technology transfer and scale-up
- Engineering (water systems, HVAC Systems)
- Statistics
- Experts in Oncology, recombinant biologics and vaccines (API & finished products)
- Project management and Certified Six-Sigma black belt (ASQ SSBB)
- Certified GMP professional (ASQ CPGP)
QMS, GMP Audits and Compliance
- Support on GMP audits (current state analysis) to overarching advice and inspection preparation.
- Mock Inspections
- Analysis of the current GMP status of a site / Gap assessment
- Preparation of Audit report and improvement measures
- Inspections of suppliers (Vendors of Raw materials, packaging materials) and contract manufacturers & testing laboratories
- Routine GMP audit and compliance support
- Monitoring your green files projects, modification/ expansion or improvement projects,
- Creation and review of GMP documents
- Building up your quality systems
- Assessment of effectiveness of quality system
- Support on building R&D quality systems
- Support on phase wise GMP implementation during product development to commercial stage
Commissioning, Qualification and Validation (CQV)
- Helping to adopt a risk-based approach and clearly the extent of qualification required in compliance to GMP.
- Monitoring complete CQV project
- Equipment / system / facility – Design Review
- Defining system boundaries
- Risk Assessment
- FAT / SAT Support
- Qualification DQ, IQ, OQ, PQ protocols – preparation, review and execution
- Software Validation
- Create / review calibration and preventive maintenance program.
Professional Trainings and Coaching
- Basic and Advanced
- GMP trainings
- Documentation skill and Data Integrity
- Deviation investigation and report writing
- CAPA management
- Process validation and Continuous process performance verification
- Analytical method validation and Continuous method performance verification
- Risk management
- Change management
- Equipment validation and life cycle management
- Use of statistical tools in trending CTPs & CQAs and in conducting product reviews
- Design and maintenance of quality system
- Product development stages and application of phase-wise GMP
- Application of Six-Sigma in pharmaceutical quality assurance and engineering services
