Regulatory Representation & Local License Holder Services Vendors
Compare partners that act as your legal representative, US Agent, device authorized representative or local license holder in markets where you have no legal entity.
Related workflows
CRO / Research Services Provider · +2 more types
Products: ClinQuick
“US agent and FDA liaison services include meeting requests and briefing package preparation”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more
Service Provider · +2 more types
Products: D.AI.M.I.
“EU MAH (Marketing Authorization Holding) and US Agency services”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Consulting / Advisory Firm · +2 more types
“FDA Representation and Interaction Serving as authorized representatives and providing coaching for.”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“In addition, Veristat can act as MAA Applicant & MA Holder in the UK, EU and Switzerland on behalf of our client’s ad interim until a legal entity is established in the EEA/CH/UK…”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Compare listed vendors
What this covers: Acting as a sponsor's or manufacturer's legally required local representative or license holder in a market where it has no legal entity: EU, UK, or Swiss legal representative for clinical trials, FDA US Agent, EU, UK, or Swiss authorized representative for medical devices and IVDs (MDR and IVDR authorized representative, UK Responsible Person, CH-REP), and marketing authorization holder, local license holder, or MAA applicant services.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Celerion | CRO / Research Services Provider | IND & CTA Regulatory Application Support, Marketing Authorization & Lifecycle Submission Support | “US agent and FDA liaison services include meeting requests and briefing package preparation”celerion.com · reviewed Oct 22, 2026 |
| Halloran Consulting Group | Consulting / Advisory Firm | IND & CTA Regulatory Application Support, Marketing Authorization & Lifecycle Submission Support | “FDA Representation and Interaction Serving as authorized representatives and providing coaching for.”hallorancg.com · reviewed Oct 22, 2026 |
| ProductLife Group | Service Provider | IND & CTA Regulatory Application Support, Marketing Authorization & Lifecycle Submission Support | “EU MAH (Marketing Authorization Holding) and US Agency services”plglifesciences.com · reviewed Oct 26, 2026 |
| Veristat | CRO / Research Services Provider | IND & CTA Regulatory Application Support, Marketing Authorization & Lifecycle Submission Support | “In addition, Veristat can act as MAA Applicant & MA Holder in the UK, EU and Switzerland on behalf of our client’s ad interim until a legal entity is…”veristat.com · reviewed Oct 22, 2026 |