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Market Access & Commercial

In-/Out-Licensing Strategy (MA, ANDAs, Dossiers)

Licensing strategy and deal support for marketing authorizations, ANDAs and dossiers — in and out.

Overview

Licensing is a powerful lever for growth and monetization — when the right assets meet the right partners on the right terms, and when the diligence behind the deal is sound. PharmExpert supports in- and out-licensing of marketing authorizations, ANDAs and dossiers, from strategy and partner identification to deal support.

We define the licensing strategy — what to license in or out, into which markets, and why — then identify and evaluate candidate partners and assets against it, so the deal serves a strategy rather than the strategy being reverse-engineered from an available deal.

Sound transactions rest on diligence. We coordinate the technical, regulatory and IP/patent due diligence that reveals what an asset is really worth and what it will cost to realize, feeding directly into valuation and deal structuring.

We support negotiation and terms and the transition that follows close, including the regulatory transfer mechanics. The result is licensing deals built on evidence and executed cleanly, not on optimism.

What we do

  • Licensing strategy (in / out) for MAs, ANDAs and dossiers
  • Partner and asset identification and evaluation
  • Valuation and deal-structuring support
  • Coordination of technical / regulatory / IP due diligence
  • Negotiation and term support
  • Transition and onboarding

Our process

  1. 1

    Strategize

    Define licensing objectives and approach.

  2. 2

    Identify

    Find and evaluate partners / assets.

  3. 3

    Diligence

    Coordinate technical, regulatory and IP due diligence.

  4. 4

    Close

    Support structuring, terms and transition.

What you receive

  • Licensing strategy
  • Partner / asset shortlist and evaluation
  • Due-diligence coordination
  • Deal and transition support

Who needs this

Companies licensing assets in or out, organizations monetizing dossiers/ANDAs, and teams entering markets via licensing.

Frequently asked questions

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