• Validation Master Plan
• IQ/OQ/PQ Protocol Writing
• IQ/OQ/PQ Protocol Execution
• Factory Acceptance Tests
• Site Acceptance Tests
• Cleaning Validation
• Equipment  Validation
• Plant Validation
• Packaging line Validation
• Process Validation
• Computer Validation (ERP, BMS, MRP, PAT, LIMS,
Laboratory equipment)
• Pre-commissioning, Commissioning
• Clean Room design and Pharmaceutical HVAC Assistance

•  Submission: 510(k), PMA, IDE, UL, FCC, CE Mark,
•  QSR/ISO 9000; 9001/ EN46001Compliance
•  ISO 13485
•  Audit

• Audit: Compliance Management, Manufacturing System,
• Plant Compliance & Validation
• NDA Submission (FDA , EMEA et CSA)
• Establishment Licence
• Regulatory Affairs Strategy

• Audit of Engineering Drawing
• Audit of Manufacturing Process
• GMP Equipment Classification & Impact Studies
• Quality Management
• Quality Manual, Procedures
• Preparation and Drafting of Specifications
• Preparation and Drafting of  User Requirement Specifications: URS, FRS, DS...

• Water system (City, Deionized, purified, WFI et USP)
• Osmosis Reverse
• Ozonation
• Clean Steam
• Cleaning-in-Place / Steam-in-Place
• Compressed Air and Medical Gas
• Ventilation System - HVAC
• Clean Rooms, Controlled Rooms
• Building Automated System (BAS)
• Manufacturing Resource Planning (MRP)

• GMP Compliance
• Quality System
• Establishment Licence
• Validation (Equipment, System, Process, Cleaning and Computer)
• Clean Steam
• Submission Dossier Compilation (CSA et FDA)
• Technical Assistance (Problem Solving)
• Training

• Documentary Research
• Access to the Documents
• Products Research
• Benchmarking
• Market Report Studies
• Competitiveness Studies
• Scientific Communication Support

• Planning and Success Criteria
• Plant & Compliance Studies
• Analytical Methods Transfer
• Active Pharmaceutical Ingredients (APIs) Transfer
• Transfer of Dosage Forms
• Risk Evaluation

Contact us for more complete information.