Contact
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Focus areas
Quality Assurance
- Quality Agreements
- Batch Record Review and Product Release
- Document Control
- Laboratory set up
- Validation: Process/Utility/Equipment/Analytical
- IND/NDA data integrity
- Stability and Validation Programs Development
- Equipment Qualification Protocols/Reports
Regulatory Compliance
- QA Strategy and Support
- GMP Compliance
- Quality Systems Development
- PAI support – FDA interaction training, data integrity, auditing, data QC
- EU requirements / QP support and interactions
- Auditing
- Training: development and presentation
CMC Support
- CMC Project Management
- CTM Supply Chain Logistics
- CMC Support
- Analytical / QC
- Contract Manufacturing Liaison
- IND/IMPD CMC section preparations
GXP Services
- GLP compliance
- Project management
- Drug Safety
- GCP compliance
- Clinical Operations/ Clinical Trial Monitoring
- Med/Tech writing