Loading…
Asphalion
Regulatory, Scientific & Safety Consulting in Life Sciences
About
Asphalion describes itself as "an international Scientific, Safety and Regulatory Affairs consultancy company" offering "expert consulting, strategic advice, operational support and full outsourcing services for all product life cycle stages." Its stated service lines are Medical & Scientific Writing, Drug Development Consulting, CMC, Regulatory Procedures, Vigilance (pharmacovigilance and medical device vigilance), Regulatory Operations (eCTD publishing and eSubmissions), Data Management, MedTech, Health Technology Assessment, and Horizon EU programmes. The company states it was founded in 2000 and has "over 200 team members," and cites "over 1,500 companies" served in "more than 50+ countries" across "over 10,000 projects."
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.
GMP expertise iAverages per-area depth across the consultant's listed GMP expertise areas - each area blends proficiency (Foundational 35 up to SME 100, 45%), years of experience (capped at 20, 25%), projects completed (capped at 40, 20%) and inspection support (10%) - then combines 78% depth with 22% breadth (14 points per area, ~7 areas = full breadth). Shows 0 - Developing with no areas listed. Levels: 85+ Elite | 70-84 Advanced | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
0Developing
Functional depth iAverages each functional specialization group - 60% its SME level (Practitioner 45 up to Authority 100) plus 40% its skill count (20 points per skill, capped) - then combines 75% depth with 25% breadth (17 points per group, ~6 groups = full breadth). Shows 0 - Developing with no groups listed. Levels: 85+ Authority | 70-84 Advanced | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
0Developing
Regulatory iAdds inspections supported (4 points each, capped at 40), remediations led including Warning-Letter and data-integrity work (5 points each, capped at 30) and regulatory agencies covered (5 points each, capped at 20), plus a 10-point credit for any Warning-Letter remediation. Levels: 80+ Authority | 60-79 Seasoned | 40-59 Experienced | below 40 Emerging. Whether this dimension matters for you depends on your specific project.
15Emerging
Engagement iHow fast and flexibly the consultant can start: availability status (Available now 35, Limited 22, otherwise 10), typical response time (same-day/24h 25, 48h 15, any stated time 8), engagement models offered (6 points each, capped at 25), plus 8 for remote availability and 7 for willingness to travel. Levels: 80+ Immediate | 60-79 Ready | 40-59 Available | below 40 Limited. Whether this dimension matters for you depends on your specific project.
10Limited
Audit readiness iCounts agencies with at least one supported inspection (FDA, EMA, MHRA, PMDA, Health Canada, WHO - 5 points each, capped at 25), total inspections and audits (1.2 points each, capped at 30), mock inspections (3 each, capped at 10), the reported inspection success rate (up to 20; assumed 70% if unreported) and remediations (2.5 each, capped at 15). Levels: 85+ Inspection-ready | 70-84 Strong | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
14Developing
Industry maturity iClinical-to-commercial lifecycle reach: commercial launches (6 points each, capped at 24), facility startups (3 each, capped at 18), greenfield plus brownfield projects (2.5 each, capped at 14), facilities supported (0.7 each, capped at 14) and manufacturing scales covered (3 each, capped at 12, plus 8 if commercial scale), plus 2 points per industry served, capped at 10. Levels: 85+ Commercial-grade | 70-84 Advanced | 50-69 Established | below 50 Emerging. Whether this dimension matters for you depends on your specific project.
0Emerging
Regulatory agencies
Certifications explicitly claimed by the company: ISO 9001:2015ISO 13485:2016 and ISO/IEC 27001:2022. No GMPPIC/S or inspectorate registrations are claimed.
Primary specializations
Medical and Scientific WritingDrug Development ConsultingChemistry Manufacturing and Controls (CMC)Regulatory ProceduresPharmacovigilance and Medical Device VigilanceRegulatory Operations (eCTD and eSubmissions)Data ManagementMedTechHealth Technology Assessment
Coverage regions
Company lists regional service coverage as: Europe (EU)EU localSpainUKUSASwitzerlandCanadaAustraliaLATAMMENA and EURASIA. Offices stated: Barcelona (headquartersCarrer Tarragona 151-15711th floor08014 Barcelona)MadridMunich and Londonplus stated "presence in Italy and Portugal." It also states it operates AsphaNet"a network of partners to provide local regulatory services throughout Europe."
Live record · illustrative seed data · scores deterministic, rules-based — not AI.