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 Obstetrics and Gynecology
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Atherectomy
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Breast Imaging
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Acute cardiac arrest intervention
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Adhesion prevention in laparascopic surgery
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Femoral artery closure
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Premature labor detection
   
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Breast biopsy devices
Dermatology
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Uterine artery embolization
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Lasers    
 
Ophthalmology
Drug Delivery
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Refractive surgery for myopia, hyperopia, presbyopia
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Drug eluting devices, combination products
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Cataract surrgery,accomodating IOLs
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Sustained release drug delivery for breast cancer, prostate cancer, retinal disease, glaucoma
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Glaucoma devices and drug delivery
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Retinal detachment
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Age-related macular degeneration
Gastroenterology
Pulmonary
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GERD treatment
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COPD/ emphysema implants, surgical devices
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Surgery, neurostimulation for obesity
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CAD imaging system for lung cancer
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Endoscopes    
    Urology
Neurology / Neurointerventional
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Bulking for female urinary incontinence
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Stroke    
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Thermoregulation and cooling    
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Liquid embolics agents for AVMs, aneurysms    
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Aneurysm coils    
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Clot retrieval devices    
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Middle cerebral artery (MCA) stent for stroke prevention    
       

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 succesful regulatory planning and execution.

 

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