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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.

For professional firms

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.

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Answers cite WONE Global's sourced statements and show how each one was checked. Research, not advice.

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

Launch a regulated product or service

Can we launch our product in this country, or does it need approval first?

WONE Global confirms how the product or service is classified, which approvals, registrations and labelling rules apply, and prepares the filings with a regulatory professional in each market.

Countries in the typical case Australia · Germany · France · Netherlands

The situation

What is happening

What is at stake

A regulated product launched without approval can be withdrawn, seized or fined, and the launch date is lost.

A scenario

Food supplement brandMid-sized company · from Australia · in Germany, France, Netherlands

It plans an EU launch and is not sure its ingredients and health claims are allowed.

Where it ends A product and label that can be sold, and a launch order that makes sense.

A representative scenario of the work WONE Global coordinates, not a specific client’s matter.

Also asked as “What approvals does our product need abroad?”“Is our service regulated in this market?”“A medical device is not approved for sale in a target market”

The solution

How WONE Global handles it

WONE Global confirms how the product or service is classified, which approvals, registrations and labelling rules apply, and prepares the filings with a regulatory professional in each market.

Usually led by Licences, permits and regulators, with Contracts and commercial law and Anti-bribery, sanctions and compliance.

Step by step, in the scenario

  1. Day 1WONE Global sends the formulation and labels to regulatory professionals in the launch markets.
  2. Week 1Each ingredient and claim checked; notification rules confirmed.
  3. Week 2Reformulation and label changes listed, with filings prepared.
  4. ThenNotifications filed; launch planned market by market.

Timings are typical. They depend on the countries, the authorities involved and how quickly documents are available.

Decisions

The decisions involved

  1. 01Which regulator and which authorisation route applies
  2. 02Product, labelling, data and consumer-law requirements
  3. 03What can launch now and what must wait for approval

Outcomes

What you receive

  • A regulatory pathway and filing plan
  • Compliant product documentation and terms
  • A launch checklist signed off by the local professional

This is a general guide. Your WONE Global professional confirms the work, timing and fees for your markets before anything starts.

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 involvedContracts and commercial law12 markets with a named lead→
  3. Often involvedAnti-bribery, sanctions and compliance3 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. Australiain the typical case On request Availability confirmed before any work begins Bring a requirement →
  2. Francein the typical case On request Availability confirmed before any work begins Bring a requirement →
  3. Germanyin the typical case On request Availability confirmed before any work begins Bring a requirement →
  4. Netherlandsin the typical case On request Availability confirmed before any work begins Bring a requirement →
  5. Colombia WONE Global Partner Katherin Diaz Velilla · Co-Founder Brief this Partner →
  6. India On request Availability confirmed before any work begins Bring a requirement →
  7. Saudi Arabia On request Availability confirmed before any work begins Bring a requirement →
  8. Singapore On request Availability confirmed before any work begins Bring a requirement →
  9. United Arab Emirates On request Availability confirmed before any work begins Bring a requirement →
  10. United Kingdom On request Availability confirmed before any work begins Bring a requirement →
  11. 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…

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…

Roberto GilardinoShanghai · China

WONE Global Capability Partner · China

Roberto Gilardino

Regional Partner North Asia & additional countries · Horizons (Shanghai) Corporate Advisory Company · Shanghai

Roberto Gilardino is Regional Partner at Horizons, supervising the advisory’s activities in North Asia as well as additional countries (including Mongolia, Malaysia, Indonesia, Pakistan, UAE, Cyprus and Malta).

WONE Global Intelligence

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