3llcconsulting

3LLC Consulting sells business-to-business advisory packages that bundle regulatory compliance, quality-management system implementation, and technical training for medical-device, IVD, and combination-product companies. Offerings range from fixed-price “starter” compliance kits (≈ $5–10 k) to premium on-site retainer programs that can exceed $150 k; all are delivered remotely or on-site, with scoping, contracting, and document delivery handled through the firm’s online client portal. The firm is staffed entirely by former FDA reviewers and ex-industry RA/QA directors who average 15+ years of direct 510(k), PMA, CE, and QSR experience, allowing them to promise first-round submission acceptance rates above 90 %. Their proprietary “Pre-Sub-to-Clear” playbook and ready-made DHF/TF templates are frequently cited in industry webinars as de-facto benchmarks for lean regulatory strategy. Primary buyers are early-stage med-tech CEOs, regulatory VPs, and venture-backed start-ups that need market clearance within 12–18 months to unlock Series B funding. Clients value speed, audit-survival certainty, and the ability to outsource entire RA/QA functions without building internal staff. 3LLC competes against multinational regulatory consultancies and boutique law firms; it differentiates through ex-FDA insider expertise, flat-fee transparency, and a guarantee to join FDA meetings as official regulatory counsel—services the larger generalist firms normally exclude or bill as extras.