For healthcare product owners

A safer route to a European partner

Market entry, licensing and divestment for pharmaceuticals, herbal medicinal products, medical devices, food supplements and cosmetics.

Secure the first pass. Invest only when the evidence supports the next step.

Pharmaceutical executives and a scientific adviser reviewing a European market-entry program
01

One controlled program
from first screen to partner transaction

European market entry

A good product can still fail as a European opportunity

European partners evaluate the whole asset—not only the product idea. The current five-lane scope excludes in-vitro diagnostics.

01

Ownership

Clear rights, inventorship, licences and authority to transact.

02

Evidence

Traceable quality, clinical, technical and manufacturing records.

03

Compliance

Correct category, claims, pathway and responsible operators.

04

Commercial case

A credible buyer need, differentiation and workable economics.

Scientists researching plant-derived materials and extracts in an analytical laboratory

The self-managed route

Doing it alone creates a chain of avoidable failure points

Unclear product status

The intended use, presentation, ingredients or technical characteristics may point to a different category and pathway than the owner expects.

Fragmented advisers

Legal, regulatory, quality, clinical, manufacturing and commercial advisers may each answer a narrow question without controlling the combined programme.

Weak transaction preparation

A buyer may see incomplete ownership records, unsupported claims, missing technical evidence, an unstructured data room or an unclear funding plan.

Unwanted liability

The owner accepts manufacturer, importer or representative duties without planning for them.

Premature outreach

Approaching potential partners before the asset is ready can create an early rejection that is difficult to reverse.

Weak negotiation

An incomplete data room and weak positioning reduce leverage and value.

The result is usually not one large failure. It is a sequence of small decisions that consume time, cash and credibility.

What European partners look for

Risk is removed before value is discussed

Hartington prepares the asset for this screen before confidential outreach begins.

Clean ownership
Controlled data room
Credible evidence
Defensible claims
Funded pathway
Buyer relevance
Partner-readyasset

The secure path

Uncertainty becomes staged investment decisions

Each gate protects the client from funding the next stage too early.

1

Screen

Confirm ownership, product identity, commercial objective, existing evidence, funding limits and decision-makers.

2

Assess

Map likely category, claims exposure, evidence gaps, pathway choices, target markets, economics and partnerability.

3

Repair

Close only the gaps that are material to the selected European route and future partner diligence.

4

Validate

Test the partner thesis through controlled market soundings and evidence-based buyer logic, without broad premature exposure.

5

Transact

Prepare the data room, shortlist, outreach, negotiation process and licensing or divestment mechanics.

At every gate: STOP, REPAIR, PROCEED or PROCEED SUBJECT TO STATED CONDITIONS — with a documented reason and a defined next investment decision.

Client benefits

Control before major spending starts

01

Protect capital

Stop weak or premature projects before external costs escalate.

02

Focus effort

Close the gaps that affect partner interest, compliance and value.

03

Improve leverage

Approach partners with a coherent story, evidence package and transaction logic.

04

Keep one program view

One accountable commercial lead coordinates specialists, decisions and timing.

Hartington does not promise approval or a transaction. It gives the client earlier, better and more defensible decisions.

Risk protection

Keep the most damaging risks outside the mandate

Risk screened outWhat the client keeps
Unclear ownership or hidden obligations✓ A clean mandate and authority to negotiate
Wrong classification, claims or pathway✓ A defensible route and documented assumptions
Missing or unreliable evidence✓ A prioritised gap plan before major spend
Unfunded statutory or post-market duties✓ Clear role boundaries and funded responsibilities
Sanctions, payment or integrity exposure✓ Screened counterparties and payment routes
Premature or conflicted partner outreach✓ Controlled access and a protected process

Five product lanes

One controlled commercial process

Pharmaceuticals

European licensing, divestment or development partnership.

Programme architecture, asset positioning, partner strategy and transaction support

Medical devices

European route, commercial partner and/or distribution strategy.

Readiness review, evidence and technical-file workplan, partner preparation

Food supplements

Compliant market-entry plan and commercial partner route.

Claims and evidence workplan, product positioning and partner preparation

Cosmetics

European commercialisation and distribution/brand partnership.

Safety-file and claims readiness workplan, partner and deal preparation

Herbal medicinal products (including traditional herbal medicinal products)

European development, registration and licensing or commercialisation partnership.

Partnerability assessment, pathway and evidence workplan, product positioning, specialist coordination and partner strategy. Hartington brings specialist expertise in this category.

Clear responsibility

Role boundaries protect the client and Hartington

Client / product owner

Owns the product, rights, data, funding and statutory product responsibilities.

Hartington

Controls the commercial programme, evidence map, decision gates and transaction narrative, including partnerability assessment, specialist coordination, positioning, outreach and negotiation.

Qualified specialists and operators

Provide formal legal, regulatory, safety, conformity, quality or statutory services where required. Those experts retain responsibility for their professional opinions and statutory work.

Hartington does not become the legal manufacturer, European authorised representative, importer, Marketing Authorisation Holder, responsible person or statutory operator unless a separately governed, staffed and insured arrangement is approved.

First engagement

Can your product pass the first gate?

Tick what is already clear. This is an orientation tool—not a regulatory or legal conclusion.

Start a confidential conversation

Tell us what you want to bring to Europe

Begin with non-confidential information. Hartington will confirm whether the asset fits the first screen and what should happen next.

Email
Websiteeurope.hartington.org
BaseSpain · working internationally

Submitting opens your email application with the enquiry addressed to Hartington. You can review it before sending.

Start securely

Expand only when the evidence justifies it.

Discuss your asset