ClinReg Consulting Services, Inc. was founded in 1998 to provide clients in the medical device and pharmaceutical industries with a responsive, flexible team approach to managing the challenges of clinical and regulatory issues. Since that time, we have been instrumental in helping many companies successfully gain approval from the FDA.

The ClinReg team is composed of experts from a range of disciplines, ensuring that our clients benefit from our remarkable depth of regulatory experience and clinical understanding.

Client companies represent all major medical specialties, including urology, gynecology, neurology, neurointerventional radiology, dermatology, ENT, cardiology, gastroenterology, general surgery, plastic surgery, and ophthalmology.

Our expertise encompasses the full range of clinical disciplines:

Cardiovascular

  • Atherectomy
  • Acute cardiac arrest intervention
  • Femoral artery closure

Dermatology

  • Lasers

Drug Delivery

  • Drug eluting devices
  • Sustained release drug delivery for breast cancer, prostate cancer, retinal disease

Gastroenterology

  • GERD treatment
  • Surgery, neurostimulation for obesity
  • Endoscopes

Neurology

  • Stroke
  • Thermoregulation and cooling

Neurointerventional

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

Obstetrics and Gynecology

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

Ophthalmology

  • Refractive surgery; myopia hyperopia, presbyopia
  • Cataract surrgery
  • Glaucoma devices and drug delivery
  • Retina drugs, implants

Pulmonary

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

Urology

  • Polymers for female urinary incontinence

Our specialized skill and insight can go to work early in the product 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 that they can achieve their all-important product approval objectives.

Thorough, flexible and 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.