Consulting Services

Inspired Therapeutics maintains a core staff of expert personnel and consultants with expertise in the following areas:

Business Development

  • Strategic Planning
  • Investor Presentations
  • Reimbursement
  • Commercialization Plans
  • Exit Strategies

Clinical Affairs

  • Clinical Synopsis, Protocols

Quality Management System (QMS)

  • Training
  • SOP development
  • Implementation of Part 11 Compliant Document and Record Control systems
  • Supplier Qualification Audits
  • ISO Certification Consulting and Support

Regulatory Affairs

  • FDA Correspondence and representation
  • Q-Submission / Pre-Submission support

R&D/Engineering Support

  • Mechanical
  • Electrical
  • Software
  • Manufacturing
  • Human Factors
  • Verification and Validation Plans
  • Test Procedures, Protocols and Reports
  • Risk Management and Risk Analysis documentation support

Statistics

  • Statistical Plan
  • Statistical Analysis

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