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"This is a quote from a happy client."
Head of Clincal Something or other - Strong Memorial Hospital |
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Areas of Expertise
The areas of expertise below cover specific activities and areas of experience that CSI can offer.
Compliance
- Provide services for GMP, HIPAA, Clinical Trials, Quality Assurance, Risk Analysis, GAP analysis, and consent decree remediation.
- 21 CFR Part 11 Specialists.
- Procedures and customized training module development.
Audits / Inspections
- FDA "mock" inspections (GxP)
- Due diligence audits and assessments
- Facility design evaluation
- Pre-Approval Inspection (PAI) readiness
Quality Assurance
- Quality Assurance oversight of contract services (manufacturing, testing and toxicology)
- Document system development/review
- Computer Systems - Data Integrity / Electronic Records and Signatures
- Computer Systems - Good Automated Manufacturing Practices (GAMP)
Project Management
- Strategic Planning and Business development
- Development of timelines, budgets, and personnel requirements for tech transfer
- Selection, costing and placement of manufacturing / research equipment
- Vendor Management
Quality Control
- Development/review of CMC section of regulatory submissions
- Process development / technology transfer
- Manufacturing operations management
Validation / Qualification / Optimization
- Overall Validation Program Assessment
- Drafting Validation Master Plans
- Manufacturing processes
- Facilities
- Equipment
- COTS Software with Equipment
- Analytical assay development assistance / assessment
- Identity, purity, potency, stability testing
- Identification / oversight of Contract Manufacturing Organizations (CMOs)
Clinical Trials
- Assist with the conduct of clinical trials
Training
- In-house training. Pre-developed courses and development of specialty courses
Automation
- IQ/OQ/PQ on all types of equipment
- Design and implementation strategies
- Method transfer
- Training
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