External FDA Consulting
NUCATS is pleased to refer Northwestern University innovators to an available FDA consultancy firm. This firm is contracted under an executed master agreement with Northwestern University.
Teams can establish specific Statement of Work (SOWs) under this agreement, tailored to their specific needs. Work order pricing can be outlined to project milestones and timelines.
Please note that the costs of the consultancy fall to the responsibility of the investigator. Investigators must secure adequate funding prior to signing an SOW.
Subject Matter Experts
There are subject matter experts on the following topics:
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CMC (Chemistry, Manufacturing, & Controls): Regulatory, Quality, & Technical
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Non-Clinical/Toxicology
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Clinical & Medical Writing Services
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Medical Devices
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Combination Products
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Regulatory Affairs & Project Management
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Regulatory Operations: E-Publishing & Submissions for...
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Pre-INDs: Pre-Investigational New Drug Application
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INDs: Investigational New Drug Application
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IDEs: Investigational Device Exemption
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BLAs: Biologics License Application
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NDAs: New Drug Application
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ANDAs: Abbreviation New Drug Application
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DMFs: Drug Master File
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Intake Meeting
- Please contact Katie Hammond and Dr. Richard D'Aquila for an intake meeting to discuss your proposed project and consulting need.
- After confirming the need for consulting and the funding plan, NUCATS will connect the investigator and any designees to the vendor for SOW establishment.
- This meeting also serves to connect investigators to other relevant resources and faculty who may be able to assist in the development of their proposed innovation and research.
- Additionally, the consulting team may be available for ad-hoc regulatory support which is brief in nature. Applicable hourly rates from the firm will apply. NUCATS can inform you of the current rates during the internal intake meeting.
Preparation
Prior to the meeting taking place, we ask that investigators email a half-page draft with the following information:
- Background
- Brief description of technology
- Rationale
- Initial Consultancy need, if known
- Longitudinal plans
- Collaborators
Feedback & Support
- Consultancy relationship are typically long-term. Research development and commercialization planning is a process with many steps and deliverables. NUCATS seeks to support our innovators with this progression and seeks consistent feedback.
- Please email Katie Hammond and Dr. Richard D'Aquila if support is needed while your project is under external consultancy.
- A formal feedback survey will also be sent to you annually.
- Please note that the CCR Regulatory team can now support annual renewal submissions to the FDA, as well as amendments not requiring consultation. Please see this fiscal year's rate sheet for the inclusive service fee.
