We Know Regulatory Inside and Out

We have a hand picked team with experience to handle all aspects of your regulatory projects.

Industry Experts

Our team has hundreds of years of combined experience in industry and at FDA. We have working experience in small start-up organizations to Fortune 500 multinational conglomerates. We understand the difference in business environments regulatory departments face based on the size of the organization they are supporting.

When it comes to supporting your project, we hand-pick the team member based on their experience and your project requirements. Our team has the expertise to make an immediate impact on your project by supporting all phases of the product lifecycle.

Pre-Market Support

  • Regulatory Strategy US/EU/CA/ROW
  • Test Protocol/Report Reviews & Approvals
  • Project Deliverables for US/EU/CA/ROW
  • Regulatory Submissions (IND, NDA, 510(k) PMA, HUD, HDE)
  • International STED Development
  • Marketing Strategy Support
  • Due Diligence

Post-Market

  • Quality & Compliance Audits
  • Regulatory Agency Interactions
  • FDA-483 and Warning Letter Responses
  • Quality System Remediation Support
  • Consent Decrees
  • Supplier Controls
  • Manufacturing & Operations Change Management
  • Recall Support, Design Changes & CAPA
  • UDI Implementation & Maintenance
  • US Agent Services& Establishment Registration
  • Device Listing & Complaint Handling
  • Pharmacovigilance & MDRs