Luminance Health

What Luminance Health does

Luminance Health is a Basel-based boutique life science consultancy founded in March 2025 by Shayesteh Fürst-Ladani (CEO) and Walter Fürst (COO), operating as Luminance Health AG under Swiss corporate law. The firm provides personalized, expert-led cross-functional consulting to pharmaceutical, biotechnology, and medical device/IVD organizations across the product lifecycle, spanning early development, regulatory approval, launch, and post-marketing activities. The service portfolio comprises ten integrated modules — Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Devices & IVDs & Combination Products, Public Affairs, Medical & Regulatory Communication, Market Access, Healthcare Compliance, Project Management, and Set-up and Scale-up of Companies — designed to be delivered as holistic cross-functional engagements.

The company's technical foundation is a Swissmedic-licensed GxP Quality Management System that meets Swiss regulatory authority requirements, alongside EMA Small and Medium-sized Enterprise (SME) certification that enables navigation of non-EU clients through the EMA submission process. These credentials allow the firm to act as Responsible Person on Swiss establishment licences and to deliver EU QPPV/UK QPPV pharmacovigilance mandates. The firm supplements in-house capability with a transatlantic strategic partnership with Advyzom LLC (a Danforth Health company) for US regulatory expertise, and operates through offices in Basel (headquarters, Hochstrasse 31) and Austria, with a global partner network extending reach beyond the DACH region.

Luminance Health operates a professional services revenue model through project-based engagements and ongoing advisory mandates with enterprise clients; pricing is quote-based and not publicly disclosed. The go-to-market is consultative and relationship-driven, leveraging industry events, educational webinars, and professional network participation across organizations such as Swiss Biotech Day, BioValley, and Pharma Women's Network. The firm has grown to approximately 22-23 team members in its first year, serving more than 30 clients across the United States, Switzerland, the European Union, and China. Notable recognition includes Great Place To Work certification (100% scores in credibility, fairness, pride, and camaraderie) and a #1 ranking as Best Workplaces Switzerland 2026. The company operates without disclosed external institutional funding as a founder-owned entity.

Name

Luminance Health

Legal name

Luminance Health AG

Website

https://luminance-health.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

11–50 employees

Short description

Luminance Health is a Basel-based boutique life science consultancy providing cross-functional expert-led consulting in regulatory affairs, quality assurance, pharmacovigilance, medical devices, market access, public affairs, and compliance to pharmaceutical, biotechnology, and medtech organizations across global markets.

Ownership category

akta.pro rank

Product category

Life Science Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

akta.pro secondary industries

Medical Affairs, Scientific Communications & HEOR FSP (HLAGAOAG), Healthcare & Life Sciences PR (MPAAADAD)

Keywords

• Regulatory affairs consulting
• Pharmacovigilance services
• Quality assurance consulting
• Market access strategy
• Medical device compliance

Headquarters

HQ city

Basel

HQ country

Switzerland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Consulting Services: Cross-functional consulting services including regulatory affairs, quality assurance, pharmacovigilance, medical communications, market access, public affairs, healthcare compliance, and project management. Revenue generated through project-based engagements and ongoing advisory mandates.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Luminance Health is a boutique life science consultancy delivering personalized, expert-led cross-functional consulting services to pharmaceutical, biotechnology, and medical technology organizations. The firm offers ten integrated service lines covering Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Devices/IVDs/Combination Products, Public Affairs, Medical & Regulatory Communication, Market Access, Healthcare Compliance, Project Management, and Company Set-up & Scale-up, supporting clients across the full product lifecycle from early development through commercialization. Services are delivered through direct, project-based engagements and ongoing advisory mandates from offices in Basel, Switzerland and Austria, supported by a global partner network.

Product overview

Luminance Health is a premium life science consultancy offering personalized, expert-led cross-functional consulting services rather than a unified software product. The company provides ten integrated service modules: Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Devices & IVDs & Combination Products, Public Affairs, Medical & Regulatory Communication, Market Access, Healthcare Compliance, Project Management, and Set-up and Scale-up of Companies. These services are designed to work together holistically to support pharma, biotech, and medtech organizations across the full product lifecycle from early development through commercialization and beyond.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Strategic regulatory advice and hands-on operational support throughout the lifecycle of drugs and ATMPs, from early development to registration, launch, and post-marketing, including CTA/IND preparation, scientific advice, MAA/NDA/BLA submission, and lifecycle management. Targeted at pharmaceutical and biotechnology organizations.
• Quality Assurance GxP compliance services including QMS development, clinical quality management, CDMO/CRO oversight, GLP/GCP/GMP audits, inspection readiness, and post-market quality systems support for pharmaceutical, medtech, and combination product companies.
• Pharmacovigilance Comprehensive pharmacovigilance services including EU QPPV/UK QPPV mandates, PSMF creation, PV system design and maintenance, signal management, RMP and aggregate reports, and regulatory intelligence for Swiss, EU, and UK markets.
• Medical Devices & IVDs & Combination Products Regulatory strategy, gap analysis, technical documentation, clinical evaluations, and conformity assessment for medical devices (including software), IVDs, and combination products across global regulatory frameworks including EU MDR, FDA, Swissmedic, NMPA, and PMDA.
• Public Affairs Policy intelligence, strategic support, advocacy, and association management services including stakeholder mapping, government relations, event management, and corporate positioning at the intersection of policy, strategy, and advocacy.
• Medical & Regulatory Communication Scientific and medical communication services including conference abstracts, manuscripts, white papers, regulatory dossier writing, regulatory intelligence, and strategic insights for pharmaceutical, biotech, and medtech companies.
• Market Access Market access roadmap, pricing and reimbursement strategy, HTA dossier preparation, early access pathways, payer engagement, and negotiation support to maximize product reach across healthcare systems.
• Healthcare Compliance Framework advising for HCP/HCO/PO interactions, promotional material review, Person Responsible for Advertising in Switzerland services, SOP creation, training, and audits for healthcare compliance.
• Project Management Cross-functional project management throughout product development and launch, including stakeholder management, project planning, timeline and budget tracking, and cross-functional team meeting moderation.
• Set-up and Scale-up of Companies Strategic advice and operational support for founding and scaling life science companies in Switzerland, EU, and UK, including company registration, compliance, HR support, interim management, and oversight of legal, permits, IT, finance, and VAT.

Quantifiable outcome

• 100% employee satisfaction scores on Great Place To Work certification
• +1 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Advyzom LLC (Danforth Health)coreStrategic or Co-development Partner · 9 February 2026Strategic partnership to deliver transatlantic regulatory expertise for life science companies. Combines Luminance Health's European regulatory expertise with Advyzom's US regulatory strategy, scientific communication, and Health Authority submissions expertise. Creates integrated global development pathway supporting clients from early development through regulatory approval, launch, and beyond. Enables companies to navigate complex global regulatory landscapes with harmonized development pathways.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• RWS Group: Global language, IP, and life sciences services firm with regulatory and medical writing capabilities within its Life Sciences division; larger player adjacent to Luminance's scientific and medical communications work.
• ICON plc: Global CRO with broad clinical and regulatory consulting services; much larger scale than Luminance, offers overlapping regulatory capability as part of a wider drug development portfolio.
• Parexel International: Major global CRO offering regulatory consulting as part of end-to-end drug development services; established incumbent with overlapping regulatory strategy and submissions capability.
• IQVIA: Largest global CRO with regulatory consulting bundled within clinical and commercial offerings; significant competitor in regulatory strategy with the scale to cross-sell against boutique specialists.

Direct peers

• ProPharma Group: Global regulatory and compliance consulting firm providing outsourced regulatory affairs, quality, and pharmacovigilance services to pharma, biotech, and medical device companies; directly comparable in multi-disciplinary life sciences consulting.
• Veristat: US-based biostatistics and regulatory consulting firm serving small and mid-sized biotech sponsors; comparable in regulatory strategy and cross-functional clinical consulting for emerging life science clients.
• PharmaLex: International consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services for pharma and biotech; directly overlaps with Luminance's regulatory, PV, and quality offerings across Europe and globally.
• Voisin Consulting Life Sciences: European boutique regulatory and quality consulting firm serving pharma, biotech, and medtech clients with regulatory strategy, clinical development, and GxP services; closest direct comparable in cross-functional regulatory consulting model.
• NDA Group: European regulatory and HTA consulting firm advising pharma and biotech on regulatory strategy, scientific advice, and market access; directly comparable in regulatory strategy and market access services.

Emerging players

• MakroCare: Smaller boutique CRO focused on regulatory affairs and clinical research for emerging pharma and biotech; partial overlap with Luminance's boutique regulatory-affairs orientation but broader clinical scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/luminance-health

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Luminance Health