WHAT WE DO...

We offer a variety of services to our clients including

  • GLOBAL STRATEGY
    • Create global regulatory strategy
    • Determine device classifications
    • Select predicate (if applicable)
    • Propose Intended use / indications for use
    • Identify unique country requirements
    • Identify global clinical requirements
    • Document submission dates
    • Estimate global approval dates
    • Identify potential risks and mitigations
    • Plan distribution controls
  • REGULATORY SUBMISSIONS
    • Plan, write, format, edit, review
      • US: 510(k), PMA, IDE, Supplements, AR
      • EU: Technical Files and Design Dossiers
      • Japan: Clinical trial, Shonin, and QMS
      • International submissions
    • Communicate with reviewers
    • Manage response strategy
    • Write and review responses
    • Correspond with international
    • Create eCopy
  • TECHNICAL DOCUMENTATION
    • Review protocols, reports and raw data
      • Design validation and verification
      • Shelf life and stability
      • Test methods
      • Chemistry, Manufacturing and Controls
      • Engineering and manufacturing documents
      • Pre-clinical and clinical studies
      • Biocompatibility
      • Sterilization
    • Review product labeling
    • Review advertising and promotion
  • PROJECT MANAGEMENT
    • Work with program management
    • Partner cross-functionally
    • Build submission schedules
    • Identify deliverables needed
    • Track and manage project timelines
    • Act as Regulatory Project Manager
  • CLINICAL
    • Input to clinical trial design
    • Input to clinical study protocol
    • Prepare for pre-submission meetings
    • Develop Investigator Brochure
    • Prepare for investigator meeting
    • Review clinical study report
    • Review clinical evaluation report
    • Support IDE and IND submissions
    • Write periodic and annual reports
  • ADDITIONAL EXPERTISE
    • Support audit preparation
    • Address FDA warning letter
    • Create and deliver training
    • Create presentations
    • Mentor regulatory staff
    • Conduct research
    • Write for your company website
    • Write blog posts and newsletters
    • Travel consulting and planning

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GET IN TOUCH...

For inquiries or to arrange a consultation, send us a message.