The FDA regulates human drugs, biologics, vaccines, cell & gene therapies, medical devices, combination products and radiopharmaceuticals across the United States, operating IND/NDA/BLA pathways, a full suite of expedited programs and global GMP/BIMO inspections.
Deterministic scores · rules-based, not AIiHow these scores are obtained: each one is computed from this profile's listed attributes — capability checkboxes, certifications, capacity figures and coverage — by a fixed formula, recomputed on every page load. Deterministic and rules-based means the score comes from a fixed, transparent formula over listed attributes — the same inputs always produce the same score. It is not AI: there is no model, no learning, and no hidden weighting. Whether a score is relevant to you depends on your specific project: a capability that raises the number may not matter for your work, and a niche strength your project needs may barely move it. Capability scores are a directional starting point, not a verdict. A lower score does not disqualify a company or consultant, and no decision should rest on the score alone — always contact the company directly to confirm the specifics for your project.
Regulatory reach iCounts the breadth of the authority mandate from four profile lists: product categories (4 points each, capped at 40), submission types (3 each, capped at 30), therapeutic areas (2 each, capped at 18), and harmonization memberships (3 each, capped at 12). Levels: 80+ Comprehensive authority | 60-79 Broad mandate | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
91Comprehensive authority
Program diversity iCounts the approval programs listed on the profile - each pathway, such as an expedited or conditional route, adds 11 points, capped at 100. Levels: 75+ Full expedited suite | 50-74 Multiple pathways | 30-49 Some expedited | below 30 Standard pathways. Whether this dimension matters for you depends on your specific project.
77Full expedited suite
Inspection rigor iAdds 12 points per inspection program listed, capped at 72, plus 1 point per 200 inspections conducted per year, capped at 28. Levels: 80+ Rigorous oversight | 60-79 Strong oversight | 40-59 Active | below 40 Developing. Whether this dimension matters for you depends on your specific project.
72Strong oversight
Transparency iChecks eight yes/no transparency features - online submission portal, eCTD support, public assessment reports, guidance database, warning-letter database, inspection database, pharmacovigilance database, open-data portal - at 10 points each, capped at 80, plus 1 point per 50 published guidance documents, capped at 20. Levels: 80+ Highly transparent | 60-79 Transparent | 40-59 Moderate | below 40 Limited. Whether this dimension matters for you depends on your specific project.
80Highly transparent
Review efficiency iStarts at 110 and subtracts 5 points per month of average approval time (falling back to average review time if approval time is missing), so faster timelines score higher; the result is capped at 100. Levels: 80+ Rapid review | 60-79 Efficient | 40-59 Standard | below 40 Extended. Shows 0 with Not reported when no timeline is on file. Whether this dimension matters for you depends on your specific project.
0Not reported
Approval throughput iAdds 1 point per 2 annual approvals reported, capped at 70, plus 6 points per approval record listed on this platform profile, capped at 30. Levels: 80+ High throughput | 60-79 Substantial | 40-59 Moderate | below 40 Selective. Whether this dimension matters for you depends on your specific project.
24Selective
Regulatory positioning
The reference global regulator — broad mandate, mature expedited pathways, deep public transparency.
Governing legislation
Federal FoodDrugand Cosmetic ActPublic Health Service Act21 CFR
Harmonization & memberships
ICHPIC/SIMDRFICMRA
Regions / territories covered
United StatesUS territories
Official languages · English
FDA
U.S. Food and Drug Administration
National agency · USA
Live record · illustrative seed data · scores deterministic, rules-based — not AI.