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Market Access & Commercial

Due Diligence (IP & Patents)

Technical, regulatory and IP/patent due diligence to de-risk licensing, acquisition and entry decisions.

Overview

Licensing and acquisition decisions carry technical, regulatory and intellectual-property risk that headline data rarely reveals — and the gap between an asset's pitch and its real condition is where deals go wrong. PharmExpert provides due diligence spanning technical and regulatory condition and IP/patent position, so deal teams decide on evidence rather than optimism.

On the technical and regulatory side we assess CMC and manufacturing, quality-system and compliance history, regulatory status and the quality of the dossier and data — surfacing the issues that determine whether the asset can actually deliver what the deal assumes.

On the IP side we assess the patent landscape, freedom-to-operate and exclusivity considerations, coordinating with IP counsel where needed, because a strong product with a weak patent position is a very different proposition.

We quantify the risks and the remediation effort and cost, then give a clear-eyed verdict that deal teams can act on — and that can inform valuation. Speed matched to deal timelines, with rigor concentrated on the highest-risk areas.

What we do

  • Technical and CMC due diligence
  • Regulatory status and dossier-quality review
  • Patent-landscape and freedom-to-operate assessment
  • Exclusivity and IP-risk evaluation (with IP counsel)
  • Risk and remediation quantification
  • Due-diligence report for deal teams

Our process

  1. 1

    Scope

    Agree the asset, data room and key risks.

  2. 2

    Assess

    Review technical, regulatory and IP condition.

  3. 3

    Quantify

    Estimate risk, remediation and exclusivity.

  4. 4

    Report

    Deliver a clear due-diligence verdict.

What you receive

  • Due-diligence report
  • Technical / regulatory risk register
  • Patent / FTO assessment
  • Deal-team briefing

Who needs this

Investors and acquirers evaluating assets, companies in/out-licensing, and teams needing an independent technical and IP verdict.

Frequently asked questions

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