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Cases · Specialist sectors · Healthcare, life sciences & medical regulation

A medical distributor has breached territorial restrictions

Usually led by Government & Regulatory Affairs, with Intellectual Property & Brand Protection and Legal & Contracting. WONE Global brings the areas of expertise and countries together, with a named professional in each market where one is published.

The situation

What is happening

Approvals, licences, trials, data, IP and transactions in healthcare.

The first questions

  • Which product or service, and which markets?
  • Which regulator and approval route?
  • Is patient data involved?
  • Is there a safety issue now?

Who faces this

  • Healthcare enterprises
  • Manufacturers
  • Investors

Cross-border complications to check

  • Foreign investment controlsA proposed ownership change may require sector or national security clearance · Government & Regulatory Affairs
  • Merger control timingA proposed transaction may need clearance in multiple markets · Government & Regulatory Affairs
  • Environmental permit interfacesProjects cross regional, national or transboundary environmental regimes · Government & Regulatory Affairs
  • Different laws of contractParties sign one commercial agreement but disagree which law governs duties, damages and remedies · Legal & Contracting

The solution

How WONE Global handles it

Usually led by Government & Regulatory Affairs, with Intellectual Property & Brand Protection and Legal & Contracting.

How WONE Global usually approaches healthcare, life sciences & medical regulation

  1. 01Map regulatory routes in each market.
  2. 02Prepare filings with regulatory professionals.
  3. 03Address safety, data and IP issues.
  4. 04Support transactions and expansions.

General guidance for this subject. The route for your case depends on the countries, the deadlines and what you already hold.

Services

The services involved

One area of expertise usually leads; the others move with it. WONE Global keeps them connected across every country involved.

  1. Usually leadsGovernment & Regulatory Affairs1 market with a named lead→
  2. Often involvedIntellectual Property & Brand Protection4 markets with a named lead→
  3. Often involvedLegal & Contracting18 markets with a named lead→

Who handles it

Government & Regulatory Affairs, market by market

The status of the lead service in the markets that matter for this case. A named WONE Global Partner acts under their own licence; where none is in place yet, WONE Global confirms availability before anything else.

  1. Colombia WONE Global Partner Katherin Diaz Velilla · Co-Founder Brief this Partner →
  2. India On request Availability confirmed before any work begins Bring a requirement →
  3. Saudi Arabia On request Availability confirmed before any work begins Bring a requirement →
  4. Singapore On request Availability confirmed before any work begins Bring a requirement →
  5. United Arab Emirates On request Availability confirmed before any work begins Bring a requirement →
  6. United Kingdom On request Availability confirmed before any work begins Bring a requirement →
  7. United States On request Availability confirmed before any work begins Bring a requirement →

Other markets: WONE Global covers 100 countries. Name yours in the requirement →

Katherin Diaz VelillaBogotá · Colombia

WONE Global Partner · Colombia

Katherin Diaz Velilla

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, trans…

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UNIONE™ · Before You Arbitrate™

If this becomes a dispute, test it first.

Test the claim or the defence, the evidence, the exposure and the settlement options before committing to formal proceedings.

For this moment

UNIONE™ is the UNBOUNDED™ Global Ecosystem's institution for cross-border dispute prevention, resolution, arbitration and enforcement. Like WONE Global, it is part of the ecosystem, and the two work as one. Links open theunione.org. Visit UNIONE™