Our commitment to helping you achieve success begins with our first conversation. ClinReg's team goes to work immediately to develop a profile of your product and define your precise clinical and regulatory needs.
We translate the complexities of FDA submission, review procedures and communications into manageable steps that help you achieve your clinical and marketing goals.
What we do:
- Define regulatory strategy
- Develop proposals to FDA and organize meetings (Pre-IND, EOP2, Pre-NDA, pre-submissions (IDE, PMA, 510K), denovo, HUD)
- Manage FDA communications
- Prepare submissions – all or part, tailored to client needs including IND, IDE, HUD, HDE, RFD, 510K, PMA and NDA
- Strategic clinical data management and reporting – data management plan, statistical analysis plans, database development and validation, table programming and link to clinical reports
- Extensive regulatory experience across medical specialties and FDA Divisions – strong relationship with FDA, respected for quality of submissions and interactions
- Specialized expertise in drug delivery and combination products
- Experience with large number of original PMAs for Class III devices and novel technologies
- Successful presentations to Advisory Committees (lead for 10 Advisory Committees including preparation and presentation)
- Assist clients with CRO activities including adverse event determinations and reporting
- Practical approach
- Reasonable fees and flexibility
- Most importantly – excellence in every submission and communication with FDA
We welcome your inquiries. Contact us to learn how ClinReg Consulting Services, Inc. can assist your company in reaching its goals successfully.