Welcome to Regulatory Affairs.

Regulatory Affairs helps researchers successfully navigate the complex regulatory landscape to accelerate research development in the constantly changing global regulatory environment. Partnering with the investigator throughout the entire study life cycle, we ensure compliance with ethical principles and regulatory pathways that accompany pre-clinical, clinical, and translational research. Learn about the services we provide!

Starting a new project? We’re here to help.

Whether you’re an experienced researcher or starting your first project, our team can help with many core regulatory services. Please tell us about your project by completing our request for regulatory services form.

Who we are and what we believe.

We are a dedicated team of regulatory affairs specialists protecting the safety of study participants and the integrity of research studies. We set the highest standards of excellence in regulatory compliance, and we adhere to the highest ethical standards. Our specialists offer guidance on Good Clinical Practice, regulations and compliance, study design and safety oversight, best practices and regulatory submissions.

Core Regulatory Services 

Following is a listing of our regulatory services.

Regulatory Applications

• IRB submission and correspondence -initial, renewal, and amendment/modification applications
• Preparation of Consent Forms and assistance with Recruitment Materials
• Promptly Reportable Information review and submission
• Coordinating with UNC IRB and Central IRBs
• Coordinating with International teams for dual IRB submission
• Working with trainees/fellows for consultation and to review IRB/ethics submissions
• Communication with Sponsor/CRO
• Coordination of meetings and correspondence with International study teams
• Reliance Agreement Coordination

Regulatory Documentation

• Maintenance of Regulatory Files per GCP
• Preparation of Regulatory Documents -1572 form/IoR, Financial Disclosure Forms, Protocol signature pages, IB-PI Acknowledgement of Receipt
• Preparation and Maintenance Delegation of Duties logs
• Coordination of Site-Initiation, Interim, and Close-Out Monitoring Visits (not site selection visits)
• Routine QA of Regulatory Files
• ClinicalTrials.gov registration and updates (except results reporting)
• Maintenance of personnel and training files – GCP, HSP, CVs, Licenses, and IGHID Confidentiality contracts
• Tracking of staff training attestations
• Maintenance of central regulatory documents – FWA, IRB rosters, lab certifications, and reference ranges
• Tracking and Submission of IND Safety Reports
• Consent form – Q/A, filing, creation of electronic consent forms with Adobe Sign as needed

Consultation Services

• Review of protocol and consultation
• Submissions to other regulatory authorities – FDA, Institutional Biosafety Committee, Protocol Review Committee, other institutions e.g. Wake County Health Department

IND/IDE Assistance Program

• FDA Investigator Initiated IND submissions
• FDA Emergency/Compassionate Use IND submissions