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Regulatory

 

Regulatory

Blog

The 3 W’s of Regulatory Success: What to Do, When to Do It, and Why It Takes Avania

December 23, 2022

Blog

The Right Road to Approval: The Pros and Cons of
3 Regulatory Pathways

December 23, 2022

Blog

Clinical Evaluations From MDD to MDR

May 11, 2022

White Paper

Path to Approval: Why the FDA Q-Submission Program Is a Key Regulatory Strategy Component

White Paper

The Benefits of a Breakthrough: The Advantages of FDA Breakthrough Designation for Patients and Medical Device Manufacturers

White Paper

Beyond the CE Mark: How to Collect Clinical Evidence to Ensure EU MDR Compliance

White Paper

Navigating the Pre-Market EU MDR Journey

Brochure

It Takes Avania Brochure

Blog

EU Medical Device Regulation 2017/745 – First Formal Amendment, Delaying Date of Application

May 4, 2020

Blog

Post-market surveillance under a “522 order” — why, what, and how?

April 9, 2020

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Your product is important, and your trial deserves the team that has what it takes. It takes knowledge. It takes passion. It takes commitment. It Takes Avania.

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About Avania

Avania is an integrated global, full-service CRO with specialized expertise in medical device, novel technology, and combination products. They advance products from feasibility all the way through post-approval trials in analytics, clinical trials, consulting, regulatory, reimbursement, and more.

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  • It Takes Avania
    • Our History
    • Global Reach
    • Leadership Team
    • Mission, Vision, & Values
    • Testimonials
  • Services
    • Analytics
      • Biostatistics
      • Data Visualization
    • Clinical Trials
      • Field Support
      • Clinical Safety Management
    • Consulting
    • Medical Writing
    • Quality Management
    • Regulatory
    • Reimbursement
  • Solutions
    • Therapeutic Expertise
      • Aesthetics
      • Cardiovascular
      • Dermatology
      • Neurology
      • Ophthalmology
      • Orthopedics
      • Urology
    • Industry Expertise
      • Medical Device
      • Medical Technology
      • In Vitro Diagnostics
      • Biotech
    • Specialized Expertise
      • FIH and EFS
      • CER
      • Data Visualization
    • Strategic Service Provider
  • News & Events
    • News
    • Events
    • COVID-19
  • Resources
  • Blog
  • Visit Our Virtual Booth
  • COVID-19
  • Careers
  • Contact