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

A manufacturer is responding to a product safety recall

Usually led by Licences, permits and regulators, with Trade marks, patents and brands and Contracts and commercial law. 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 Licences, permits and regulators, with Trade marks, patents and brands and Contracts and commercial law.

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 leadsLicences, permits and regulators1 market with a named lead→
  2. Often involvedTrade marks, patents and brands2 markets with a named lead→
  3. Often involvedContracts and commercial law12 markets with a named lead→

Who handles it

Licences, permits and regulators, 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 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…

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