ClinReg Consulting Services Inc.

we reached out to Clinreg early on in our development for assistance in helping our company navigate premarket development and the regulatory approval process. they are an expert team when it comes to the pre-clinical process and provided a wealth of information, assistance to our research team in pushing us towards the final approval. they have experience in all clinical expertise including dermatology, drug delivery, neurology, pulmonary, urology ,etc. our development team learned a lot working with Clinreg and have continued to use the info an data they gave us for future processes.

Strengths: regulatory strategy, date management, data reporting, drug delivery, CRO

Needs to improve: none

Used ClinReg for multiple Class III filings with the FDA, including 2 clinical trials. All have gone through the FDA easily since her team insures that everything needed for the submission is in place, in a format that the FDA wants to see.

Strengths: Judy Gordon and her talented group are experts in 510K, IDE, HDE, and PMA submissions to the FDA. Her group is probably the nationwide leader in these submission by volume and clearance rate. She also has deep relationship within the FDA and has worked well with many of them, streamlining the process.

Needs to improve: None found.

Judy and her team are nothing but the best. There is no one that has more experience with Class III medical devices. She has also an amazing ability to give you a plan of action and help you execute that plan in an efficient way. If Judy tells you to do something, you do it. Her whole staff is amazing and working with her group is fun and super productive.

Strengths: FDA Expertise, Speed, Collaborative

Needs to improve: None

Judy and her team bring a wealth of FDA experience to your company. Their knowledge and history with the FDA is invaluable. Her team has made our FDA submissions and interactions much smoother. Their experience made sure our submissions included items right items and did not include items not relevant to our submission. ClinReg Consulting is a must if you want a smooth experience with the FDA.

Strengths: Clinical and Regulatory Consulting for FDA Submissions

Needs to improve: None

ClinReg has helped my company with multiple, complex submissions. Their knowledge of the system, has been critical to our regulatory success. Ans since we are a small start-up, we take full advantage of their help in preparing and compiling large submissions for delivery to FDA.

Strengths: Regulatory planning and submission

Needs to improve: none