Services

Regulatory Affairs

Renew Research has the regulatory capability, knowledge and experience to efficiently manage products throughout their regulatory life cycle. Our regulatory team navigates global and national pre- and post-market regulatory requirements in the following areas:

  • Product development and clinical investigations
  • Premarket and post market regulatory submissions
  • GxPs
  • Regulatory compliance inspections (Internal/External)
  • Regulatory review of promotion and advertising materials

Clinical Trials

View Clinical Trials & Academic Partnerships 

The Renew Research team develops, designs and implements clinical trials in compliance with GCPs for the following activities:

  • Protocol Development
  • Study Design & Analysis
  • FDA Submissions
  • Site Monitoring & Selection
  • Informed Consent
  • IRB/IEC Approvals
  • AE Reporting

Market Access

Renew Research provides expertise related to all facets of commercialization of medical products, including:

  • Health Economics
  • Medical Product Pricing
  • Health Care Policy
  • CMS, Medicare, Medicaid
  • Private payer
  • Coding & Billing