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18 specialist services, grouped by business need.

One WONE Global Partner for each service in each market. Start from what you need to do, or go straight to a service.

People & firms

The WONE Global Partners in each market.

Named senior professionals, each admitted as the one firm for a service in their country, and the firms they lead.

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Lead your service in your market.

One Partner per service, per jurisdiction, admitted by review against published criteria.

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Sourced answers on doing business across borders.

Every statement is labelled: source-checked, professionally reviewed or not yet checked, with its source and date where checked.

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Answers come from statements checked against official sources, with the sources shown. Research, not advice.

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Situations · Common situations · Specialist sectors

Healthcare, life sciences & medical regulation

Approvals, licences, trials, data, IP and transactions in healthcare. Usually for: healthcare enterprises, manufacturers, investors.

15 common situations · 4 usually cross-border

Find the one closest to yours

Where a situation has its own page, it opens there. Otherwise, bring it to WONE Global with your question already filled in.

  1. A medical device is not approved for sale in a target market Full situation page →
  2. A pharmaceutical product faces a patent challenge Bring this to WONE Global →
  3. A clinical trial needs cross-border regulatory review Usually cross-border Bring this to WONE Global →
  4. A healthcare acquisition requires licensing diligence Bring this to WONE Global →
  5. A hospital group wants to expand internationally Usually cross-border Bring this to WONE Global →
  6. A healthtech provider needs a patient data privacy assessment Bring this to WONE Global →
  7. A manufacturer is responding to a product safety recall Bring this to WONE Global →
  8. A laboratory faces an accreditation or quality audit Bring this to WONE Global →
  9. A medical distributor has breached territorial restrictions Bring this to WONE Global →
  10. A company needs a licensing review for telemedicine services Full situation page →
  11. A life sciences joint venture has disputed research IP rights Bring this to WONE Global →
  12. A health regulator has suspended a facility's licence Full situation page →
  13. A hospital seeks financing for a new overseas facility Usually cross-border Bring this to WONE Global →
  14. A healthcare provider is facing a major procurement investigation Bring this to WONE Global →
  15. A biotech startup is negotiating an international licensing deal Usually cross-border Bring this to WONE Global →

First questions

What we will ask first

  1. 01Which product or service, and which markets?
  2. 02Which regulator and approval route?
  3. 03Is patient data involved?
  4. 04Is there a safety issue now?

The approach

How WONE Global usually approaches it

  1. Step 1Map regulatory routes in each market.
  2. Step 2Prepare filings with regulatory professionals.
  3. Step 3Address safety, data and IP issues.
  4. Step 4Support transactions and expansions.

What is needed varies by country and by matter. Your WONE Global professional confirms the work, timing and fees before anything starts.

Across borders

Complications to check

Issues to assess when more than one country is involved. They are prompts, not conclusions about any country's law.

  • Foreign investment controlsA proposed ownership change may require sector or national security clearance
  • Merger control timingA proposed transaction may need clearance in multiple markets
  • Environmental permit interfacesProjects cross regional, national or transboundary environmental regimes
  • Different laws of contractParties sign one commercial agreement but disagree which law governs duties, damages and remedies
  • Foreign ownership of landAn asset buyer needs to verify permitted ownership interests and registrations

WONE Global Partners

Professionals who handle this work

Named professionals for these services. Where none is listed for your country, WONE Global names a vetted firm to you before any work starts, subject to availability and conflict checks.

Katherin Diaz VelillaBogotá · Colombia

WONE Global Capability Partner · Colombia

Katherin Diaz Velilla

Complete profile

Co-Founder · V&V Associates · Bogotá

International tax attorney and strategic advisor with 12+ years across Colombia's DIAN, Ministry of Finance, Senate, Presidency, and EY. Co-founder of V&V Asociados. Specializes in cross-border tax structuring, transfer…

Anna PawlikowskaKraków · Poland

WONE Global Capability Partner · Poland

Anna Pawlikowska

Partner · Zacharzewski & Partners Law Office · Kraków

Legal Adviser. Co-founder of the Firm. Has been advising parties on technology contracts for more than a dozen years. Specialises in intellectual property law and new technologies. Provides day-to-day legal services to …

Tony Galandi KiireKampala · Uganda

WONE Global Capability Partner · Uganda

Tony Galandi Kiire

Managing Partner · Diamond Advocates · Kampala

Tony Kiire is the Founding and Managing Partner of Diamond Advocates, where he leads the Technology, Innovation, and Intellectual Property Law practice. He is also the founder of Lawtech Associates and Consult, the comp…

Dr. Esteban Lucio MaccariBuenos Aires · Argentina

WONE Global Capability Partner · Argentina

Dr. Esteban Lucio Maccari

Managing Director · Maccari Adam & Asociados · Buenos Aires

He is a lawyer with a degree from the University of Buenos Aires and a degree in Spanish Law. He completed postgraduate studies in Strategic Business Management at the Polytechnic University of Madrid and the Glocoll at…

Editorial examples of situations that arise, not a list of WONE Global clients or matters. The specialist area is a way to find your situation, not a separate practice group.

WONE Global Intelligence

Ask about doing business across borders

Ask in your own words. Answers come from WONE Global's checked records, with every source shown, and end with the named Partner who can act. Go deeper on any point, or build a decision file.

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