Our commitment to helping you achieve success begins with our first conversation. ClinReg's team goes to work immediately to hdevelop 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.
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Define regulatory strategy |
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Develop proposals to FDA and organize meetings |
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(pre-IDE, pre-IND, pre-PMA, End-of-Phase 2, Pre-NDA) with FDA, including rehearsal and presentation |
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Manage all FDA communications |
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Prepare submissions – all or part, tailored to client needs-IDEs,INDs,HUDs/HDEs,RFDs,510ks,PMAs and NDAs |
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Strategic clinical data management and reporting – data management plan, statistical analysis plan, database development and validation, table programming and link to clinical reports |
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Develop advisory committee, presentations, rehearse presenters, conduct mock panels |
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Extensive regulatory experience across medical specialities and FDA Divison – good relationships with FDA, respected for quality of work |
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Specialize expertise in drug delivery and combination products |
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Experience with large number of full original PMAs for class iii devices / novel technologies |
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Successful presentations to Advisory Committees |
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Develop advisory committee rehearse, Presentations, rehearse presenters, conduct mock panels |
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Define and direct CRO activities |
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Practical approach |
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Reasonable fees and flexibility |
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Most important – excellence in every submission and communication with FDA |
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We welcome your inquiries. Contact us to learn how ClinReg Consulting Services, Inc. can assist your company in reaching its goals successfully. |
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