Global Regulatory Support for New
Product Development & Life-Cycle
Management

Bringing a medical innovation to market in today’s highly regulated environment can be a lengthy and costly process—especially for start-ups, or international businesses. Missteps or misunderstandings in the regulatory pathway can lead to costly delays and setbacks. Benar Consulting offers the expertise and insight needed to navigate these complexities and help you bring your device to market efficiently and compliantly.

Contact us to learn how we can support you throughout your regulatory journey.

Contact

naz@benarconsulting.com

End-to-End Regulatory Solutions

📦 Medical Device Regulatory Services

  • 510(k), De Novo, IDE, Pre-Submissions
  • Breakthrough Device Designation
  • TAP & STeP Program
  • Technical File, Design Dossier
  • MDD to MDR Transition
  • Combination Product

📈 Strategic & Operational Support

  • Regulatory Affairs Process Excellence
  • Staff Training & Mentorship
  • Regulatory Policy & Intelligence
  • Labeling, Advertising & Promotional Material Review
  • Claim substantiation Support

🌍 Global Regulatory Strategy

  • Global Regulatory Strategy Development
  • Global Regulatory Registration
  • US Agent
  • FDA Establishment Registration & Listing
  • Regulatory Due Diligence
  • Regulatory Merger & Acquisition Support
  • FDA/ Notified Body Liaison

💊 Pharmaceutical & Cosmetic Regulatory Support

  • CMC Content Development (IND, NDA, MAA, Supplements)
  • US Cosmetic Regulation & Compliance

Naz@benarconsulting.com