Did you know Duke’s Office of Regulatory Affairs and Quality (ORAQ) offers comprehensive regulatory affairs services to advance clinical research and support product development? We specialize in preclinical and early phase (Phase I–II/Early feasibility) clinical development, offering expert support to help you develop a clear, compliant regulatory strategy and engage effectively with the FDA. ORAQ is your trusted partner in navigating the path from discovery to approval.
Not sure where to start? Contact us using the form below to schedule a consultation with one of our Regulatory Affairs Scientists and discuss how we can support your product development needs.
What We Offer
- Regulatory Strategy Development
Product assessments and customized development plans aligned with FDA expectations. - CMC Regulatory Guidance
Phase-appropriate chemistry, manufacturing & controls documentation and strategy. - Clinical Protocol Review
Assessment of regulatory compliance with agency expectations - Submission Preparation & Management
Complete authoring and submission of Investigational New Drug (IND), Investigational Device Exemption (IDE), Investigational Tobacco Product (ITP) applications. - Orphan Drug, Fast Track & Breakthrough Designation Applications
Support for early access and accelerated development programs. - Regulatory Publishing & Submission Management
eCTD publishing, formatting, validation, and submission using compliant tools. - FDA Meeting Support
Comprehensive planning, preparation, and representation for FDA meetings, including pre-IND, End-of-Phase meetings, and Pre-Submissions. - Agency Communication
Expert representation and support with FDA interactions.
Why Choose us
The ORAQ Regulatory Affairs team brings extensive experience in supporting FDA-regulated clinical research, including over a decade of hands-on involvement with IND and IDE submissions across therapeutic areas. The team is comprised of regulatory professionals with backgrounds in industry and academic research, offering a deep understanding of regulatory strategy, compliance, and documentation requirements. ORAQ has supported thousands of FDA submissions, including clinical trial applications, master files, FDA meeting requests, marketing applications, and expedited program and product designation requests. The team is highly proficient in regulatory publishing (eCTD format), regulatory intelligence, and interfacing with the FDA, providing sponsors with end-to-end support from preclinical planning through early-phase clinical development. Leveraging Duke’s institutional knowledge and collaborative infrastructure, ORAQ ensures that regulatory pathways are not only compliant but strategically aligned with your research and development goals.
Tell Us What You Need
Looking for FDA regulatory affairs support? We'd love to learn more about your project and how we can help.
Fill out the quick form below, and we will follow up within 3-7 business days.