Regulatory & Compliance Experts in North Carolina Compliance Resources, LLC
Established in 2000, Compliance Resources, LLC is a privately held Better Business Bureau accredited woman-owned small business incorporated in the state of North Carolina.
Compliance Resources is comprised of regulatory and compliance experts with extensive pharmaceutical industry experience. Our goal is to carefully match our drug development and regulatory expertise to client needs and the specific scope of work. Compliance Resources provides a variety of services to the pharmaceutical industry, including, but not limited to, the following:
Offer guidance regarding the most appropriate and expeditious regulatory pathway to FDA approval and requirements that must be fulfilled; offer guidance regarding how to overcome regulatory hurdles encountered during the development process
Developing Strategic Questions for FDA, Prepare Meeting Package, Pre-Meeting Rehearsal, Attend Meeting
Write, compile and submit Investigational New Drug (IND) Applications, Abbreviated New Drug (ANDA) Applications and New Drug Applications (NDA) in Common Technical Document (eCTD) format; Clinical Study Reports (CSR); Orphan Drug Applications; Investigator’s Brochure (IB), Product Labeling; and Specialty Reports (e.g., Response to FDA information request, CAPA Resolution; Patient/Event Narratives, Briefing Documents for FDA Meetings, Annual Reports)
Document/data audits, including biostatistics review by PHD biostatistician to ensure in-text statements/conclusions are supported by data (e.g., eIND/eCTD, CSR, IB, PSUR, DSUR, ANDA, DMF/CMC Gap Analysis)
Electronic submissions via FDA Electronic Submissions Gateway
Annual Establishment Registration and Listing; Registration of protocols with www.clinicaltrials.gov
Serves as U.S. Agent for foreign pharmaceutical companies and is the point of contact for communications with FDA
Assist with process definition; write Standard Operating Procedures; develop forms, templates, and other tools; conduct internal process audits; assist with the development and execution of Vendor Management Program, including conducting GxP Audits
Conduct domestic and international cGMP, GLP, GCLP, GCP Audits, “Mock” FDA Pre-Approval Inspections (and associated activities including working with companies to develop effective deviation management systems, well managed CAPA programs, root cause analysis of unexpected quality events to promote resolution while adopting a continuous improvement approach to satisfy FDA's GxP quality systems and enhance productivity)
Phase 1 – 4 clinical trials (USA Only)
Advice on global regulatory requirements
