Quality & Regulatory Services
Method Validation
Validation & Qualification - Processes, Equipment
Method Validation
Method Validation per USP, AOAC
- Accuracy, Linearity, Range, Precision, LOD, LOQ
- Spike recvoery
- Degradation studies
- Client requested validation tests
Stability Testing
Validation & Qualification - Processes, Equipment
Method Validation
ICH, USP Stability Testing
- Accelerated and Real time conditions
- Worldwide region/zone stability studies
- Freeze & Thaw Studies
- Photostability
Validation & Qualification - Processes, Equipment
Validation & Qualification - Processes, Equipment
Validation & Qualification - Processes, Equipment
Validation & Qualification
- Process monitoring and validation
- IQ/OQ/PQ - Equipment
- Cleaning Validation
- Validation Protocols and Reports
Root Cause Analysis Investigation and CAPA
Root Cause Analysis Investigation and CAPA
Validation & Qualification - Processes, Equipment
Root cause analysis investigation
- Deviations, Out of Specifications, Out of Trend
- Corrections
- Corrective and Preventive Actions
- CAPA Effectiveness
Quality Management System & Training
Root Cause Analysis Investigation and CAPA
Quality Management System & Training
QMS - Audits, Documents & Training
- Policies, Standard Operating Procedures, Protocols, Work Instructions
- Training - GMP, ISO, Certifications
- Internal Audits, External Audits
- PDCA process flow mapping
Regulatory Registrations
Root Cause Analysis Investigation and CAPA
Quality Management System & Training
Regulatory Registrations
- Cosmetics, Natural Health Products, Medical Devices, Pharmaceuticals, Biologics
- eCTD, ICH and FDA guidelines
- Product Registrations - US FDA, Health Canada, EU, Australia