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