ClinReg Consulting Services, Inc. specializes in helping medical device and pharmaceutical companies navigate the often-daunting world of premarket development and regulatory approval.

Our clients come to rely on the in-depth expertise of our seasoned team of professionals to provide highly effective strategies for managing clinical issues and the regulatory process.


Our expertise encompasses the full range of clinical disciplines:

Cardiovascular

  • Atherectomy
  • Embolic devices
  • Femoral artery closure

Dermatology

  • Lasers

Drug Delivery

  • Drug eluting devices
  • Sustained release drug delivery for breast cancer, prostate cancer, ocular diseases

Gastroenterology

  • GERD
  • Obesity (surgical devices, implants, neurostimulation)

Neurology

  • Stroke
  • Thermoregulation and cooling

Neurointerventional

  • Liquid embolic agents for AVMs, aneurisms
  • Aneurysm coils
  • Clot retrieval devices
  • Stents

Obstetrics and Gynecology

  • Adhesion prevention in laparascopic surgery
  • Premature labor detection
  • Breast biopsy devices
  • Uterine artery embolization

Ophthalmology

  • Glaucoma drugs, devices and sustained release drugs
  • AMD, DME, geographic atrophy
  • Refractive surgery (myopia, hyperopia, presbyopia)
  • Cataract surgery

Pulmonary

  • COPD/emphysema surgery and implants
  • CAD imaging system for lung cancer

Urology

  • Polymers for female urinary incontinence

Our specialized skills and insights are useful at every stage of the project development cycle, enabling clients to tailor product planning and execution for greatest efficiency. We help clients understand and manage the complexities of FDA requirements so they can achieve their approval objectives.

Thorough, flexible, responsive, we are proud of our track record of approvals for medical devices and pharmaceuticals and combination products that represent our experience across the full spectrum of medical disciplines.

We welcome your inquiries. Contact us to learn how ClinReg Consulting Services, Inc. can assist your company in reaching its goals successfully.