Amanda Culver

Amanda Culver is a Regulatory Submission Specialist and Document Manager for Regulatory Pathways Group, serving a critical role with responsibility for all aspects of organization and production of FDA submissions including IDEs, PMAs, INDs, 510(k)s, and annual reports. She handles formatting, editing, proofing, and the final QC of documents prior to production and shipment to FDA. Ms. Culver has assisted clients with small business qualifications, payment to FDA for submission review, data entry for clinical studies, organization DSMB meetings, FDA panel preparation and organization of required documents, FDA submission cover sheets, certifications, and product/facility registrations.