Comprehensive Regulatory Consulting

Regulatory requirements impact your products for their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between your financial success and misfortune.

Our regulatory professionals ensure the safety, effectiveness and availability of healthcare products, including medical devices, biotechnology and pharmaceuticals. Our experience covers regulatory bodies in the US, Canada and Europe. Regulatory Affairs services we offer include:

  • Regulatory Gap Analyses
  • Regulatory Compliance Initiatives
    • GxPs, 21 CFR Part 11 and Annex 11
    • European Directives and CE Marking
    • FDA 510(k) Submissions to Obtain FDA Clearance
    • Medical Device Technology Validation
    • HIPAA
    • Representation before Regulatory Bodies
  • Submission Support:
    • Preparation
    • Risk Assessment and Remediation Strategies
    • Submission Changes
  • Quality and Product Certifications
    • 60601-1 2nd and 3rd Edition Safety Testing Management
    • EMC Testing Management
  • Auditing Services
    • Internal Audits and Compliance Mediation
    • External Audits and Vendor Management Compliance