Areas of Expertise

The areas of expertise below cover specific activities and areas of experience that CSI can offer.

View MEET THE CSI TEAM for further information.

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 of:

• 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