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Life Sciences & Healthcare
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Sector — Life Sciences & Healthcare · Pharma, Medical Devices & Health

Life sciences
operates globally.
Regulation doesn't.

WONE serves pharmaceutical companies, medical device manufacturers, biotech businesses, and healthcare organisations navigating the complex and jurisdiction-specific regulatory requirements of the life sciences sector across their global operations.

Submit a Brief Services in This Sector Key Issues
Senior
Partner always
48h
Brief to team
Fixed
Price before work starts
8+
Sector Professionals
Financial Services Technology, Media & Entertainment Real Estate & Construction Consumer Business Life Sciences Natural Resources Private Equity Public Sector Not-for-Profit Professional Services
—
Sector Overview

WONE in
Life Sciences & Healthcare.

Life sciences is one of the most heavily regulated sectors in every market WONE operates in — and the regulatory requirements are rarely harmonised between jurisdictions. A pharmaceutical company with products in 20 markets faces 20 different regulatory approval frameworks, 20 different pricing regimes, and 20 different compliance obligations simultaneously.

WONE's life sciences practice combines regulatory expertise with the cross-border coordination that global pharmaceutical and medical device businesses require. WONE's presence in emerging markets — where patent expiry and generic competition dynamics are playing out differently from developed markets — is a particular strength for businesses managing global portfolio strategies.

01
Multi-jurisdiction regulatory approval — EMA, FDA, and emerging market equivalents
Obtaining marketing authorisation across multiple markets requires coordinated regulatory strategy, consistent clinical data packages, and regulatory affairs expertise in every target jurisdiction — including markets where regulatory agencies operate very differently from the EMA or FDA.
02
Transfer pricing in pharma — IP, manufacturing, and distribution
Pharmaceutical companies with IP held in one jurisdiction, manufacturing in another, and distribution in a third face transfer pricing scrutiny on every intercompany flow. Documenting and defending these arrangements requires coordinated specialist advice.
03
Clinical trial compliance across multiple legal systems
Multi-country clinical trials involve compliance obligations in every country where a trial site operates — ethics approvals, regulatory notifications, data privacy requirements, and local employment law for clinical staff.
04
Cross-border healthcare M&A — regulatory and commercial complexity
Healthcare M&A involves sector-specific regulatory approvals, complex reimbursement considerations, and clinical governance due diligence that must be conducted across every jurisdiction where the target operates.
01
Services in Life Sciences & Healthcare

What we cover
in this sector.

Every service is delivered with sector expertise alongside jurisdictional knowledge — advisers who understand the specific regulatory environment, commercial dynamics, and operational reality of Life Sciences & Healthcare.

Legal
Regulatory approval strategy — multi-jurisdiction Licensing and distribution agreements Clinical trial documentation IP protection — pharmaceutical patents Product liability — cross-border Healthcare M&A Data privacy — clinical and patient data Advertising and promotional law
Tax
Pharma transfer pricing — IP and manufacturing R&D tax incentives — international Tax structuring — IP holding Patent box regimes — comparison Cross-border royalty structuring VAT on healthcare services M&A tax — pharma transactions Digital health taxation
Advisory
Healthcare M&A advisory Due diligence — pharma and medtech Market entry strategy — healthcare Regulatory pathway advisory Valuation — pharmaceutical assets Restructuring — healthcare Forensic — healthcare investigations Dispute advisory — pharma
Audit
Pharma company statutory audit Clinical trial audit GCP compliance assurance ESG assurance — healthcare sector Transfer pricing documentation review Regulatory compliance audit Financial due diligence — healthcare Manufacturing compliance audit
Submit a Brief — 48hr Team Match View Our Professionals
02
Active Regions

Where WONE delivers
in Life Sciences & Healthcare.

Europe Asia Pacific Americas Africa Middle East
03
Typical Clients

Who we serve
in Life Sciences & Healthcare.

Client 01
Multinational pharmaceutical companies with multi-country operations
Client 02
Medical device manufacturers seeking CE marking and beyond
Client 03
Biotech companies commercialising across markets
Client 04
Generic pharmaceutical companies entering new markets
Client 05
Healthcare service providers expanding internationally
Client 06
Clinical research organisations — multi-country trials
Client 07
Healthcare PE investors and acquirers
Client 08
Digital health companies with cross-border regulatory obligations
04
Life Sciences Professionals

Practitioners who
know your sector.

WONE professionals in Life Sciences combine deep sector expertise with jurisdictional knowledge — the right combination for cross-border pharmaceutical and healthcare work.

Ahmet Seytan
Ahmet Seytan
Partner
G. Saydam & Co CPA Office
Nicosia, Cyprus
Financial ServicesLife SciencesTax Europe
CA Shareesh Gadde
CA Shareesh Gadde
Director
Shami Tree Business Advisors Private Limited
Bengaluru, India
Financial ServicesLife SciencesLaw Asia
Chau Kim Hien
Chau Kim Hien
CEO
Vina TPT Company Limited
Ho Chi Minh City, Vietnam
Financial ServicesLife SciencesLaw Asia
Daiana Roselli
Daiana Roselli
Senior Manager / Associate
Estudio Canil
Buenos Aires, Argentina
Financial ServicesLife SciencesTax Americas
Ezequiel Canil
Ezequiel Canil
Managing Partner
Estudio Canil
Buenos Aires, Argentina
Financial ServicesLife SciencesTax Americas
F Miles Adler
F Miles Adler
Principal
Adler Law Firm LLC
other, United States
Financial ServicesLife SciencesLaw Americas
Fernando Tibaldi
Fernando Tibaldi
Senior Manager / Associate
Estudio Canil
Buenos Aires, Argentina
Financial ServicesLife SciencesTax Americas
Gianluigi Mollica
Gianluigi Mollica
Senior Associate
Tax Lean Associati Stp
Milan, Italy
Life SciencesReal Estate & ConstructionTax Europe
05
Insights · Life Sciences & Healthcare

Practitioner intelligence
from this sector.

Insight · Global
Pharma Regulatory Convergence: Trends Across Major Markets
WONE Intelligence
Insight · Africa
Pharmaceutical Market Entry in Africa: Regulatory Pathways
WONE Intelligence
Insight · Asia
Clinical Trial Compliance in Southeast Asia: A Practical Guide
WONE Intelligence
Related Practice Areas & WONE OS Verticals
Life Sciences & Healthcare · WONE Global

Need Life Sciences & Healthcare expertise
across borders?

Submit a brief and we will assemble a senior life sciences & healthcare team within 48 hours. Fixed price before work starts. One contact across every jurisdiction.