SCOPE OF OPERATIONS
Turn key solutions
Qualification, Validation & Calibration
Qualification, Validation & Calibration
- Turnkey projects, including design, supply, and installation
- Engineering Consultancy (Conceptual, Basic, and Detailed)
- Feasibility Study Report
- Architecture design/ Civil structural design
- Electrical Engineering design
- Project Management and Execution
- HVAC engineering design with BMS
- MEP / Utility engineering design
- Machinery selection
- Environmental engineering
- Fire safety design
- Neutraceutical plants /Veterinary
- Equipment Procurement Assistance
- Modular Clean Room Services with Epoxy Flooring
- Pharmaceutical Process and Utility Equipment
- Black Utilities with Mechanical Piping
- Direct Impact Utilities
- Documentation for Statutory compliance
- GAP analysis for Pharmaceutical plants and safety audits
Qualification, Validation & Calibration
Qualification, Validation & Calibration
Qualification, Validation & Calibration
- Training on Protocol & Performance of Activity
- Planning of Validation / Qualification Activity
- Effective Execution of Validation / Qualification activity
- Effective & Scientific Report Writing,
- Trend Preparation and Summary Report
- CSV
- Water System Qualification
- HVAC System Qualification
- Air Compressor Qualification
- Area Qualification
- Process Validation
- Cleaning Validation
- Method Validation
- Temperature Mapping
- Computerized Systems
Documentation
Quality Assurance/ Complience
Quality Assurance/ Complience
- Preparation of Site Master File (SMF)
- Preparation of Validation Master Plan (VMP)
- SOPs Writing related to R&D, WH, QA and production, and EHS
- QMS & Data Integrity Policy Writing
- Preparation of Validation/ Qualification Protocol & Reports
- Development & Preparation of Training Material, Preparation of HR / Admin Polices
Quality Assurance/ Complience
Quality Assurance/ Complience
Quality Assurance/ Complience
- General cGMP Requirements
- Process Validation & Cleaning Validation
- Effective QMS Implementation
- Utility Validation & Qualification (Water System, HVAC, etc)
- Planning APQR
- Stability Management & Retain Sample Management
- Effective Presentation for Regulatory Audits
- Effective CAPA Writing
- Risk Management
- Best Administration Practices (Housekeeping, Personnel Hygiene, etc)
- Labels & Label Management
- Best Investigation techniques & tools
"Profound trust is built on lasting outcomes"
