Strategic outsourcing of mature product portfolio

Global innovator company.

  • Wanted to outsource parts of their mature product portfolio.
  • >60 products in different therapeutic areas
  • 430 MAs in Europe, 1,900 MAs internationally (incl. CN, AUS, CAN).
  • Scope of PharmaLex support:
    • Full regulatory product responsibility
    • GRA CMC Manager
    • All publishing and submission activities
    • Piloting of PV and Medical Affairs interface.

 

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Portfolio maintenance outsourcing in highly volatile environment

Large global portfolio to be managed while client organization underwent drastic transformations

  • Portfolio of 35 products in scope.
  • Client went through several significant changes in internal organization in a short timeframe.
  • Multi-supplier situation.
  • Major remediation needs regarding change control and labeling.

 

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End-2-end portfolio maintenance (outsourcing) program

Large unstructured source repository and limited timeframe

  • Diverse stakeholders within M&A activity.
  • Short preparation timelines.
  • Regulatory activities across the world (EU, CIS, APAC, MENA, Africa, LATAM).
  • Part integration into client Quality systems.

 

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Post–M&A PharmaLex program governance

Start-up Pharma company with no REG, PV, Quality infrastructure with urgent need for Programme Governance to be established

  • Major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets) .
  • No ability to support program governance of multi-functional Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) operational activities
  • Required urgent support to provide operational activities and oversight, with the ability to establish an appropriate program governance model as required for a Pharmaceutical company.

 

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Post–M&A pharma infrastructure development

Start-up Pharma company with no REG, PV, Quality systems infrastructure, processes and limited personnel

  • Client start-up with major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets).
  • Client has no Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) capacities in-house (neither globally nor locally) to take care of the acquired portfolio and no established systems, tools or processes.
  • Needed support to handle all MAH transfers and subsequent maintenance activities for RA, PV and QM on global and local level.

 

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M&A early strategy

Need for significant M&A strategy experience and expertise to support development of divestment framework

  • Needed expert support for the negotiation phase of a significant divestment of a business unit, during negotiation and strategy development phases.
  • Wanted external support to contribute to separation agreement, transitional service agreements (TSAs) and marketing authorization transfer (MAT) planning / implementation phases
  • Challenge to simplify the complexity of MATs to a simple model for ease of communication.

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Full PV service outsourcing

Lack of capability of handling unpredictable and fluctuating amount of cases

  • Client required outsourced PV service.
  • QPPV, database set-up and maintenance case management (clinical and post-marketing).
  • Case workflow set-up from initial receipt to reporting.
  • Listings and query support from database.
  • Reporting compliance responsibility.
  • PSMF maintenance.

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Local lifecycle Regulatory Affairs management

Local affiliates require support for mature product portfolio in DE / FR / IT

Global life science company.

  • Responsible for product portfolio needed.
    • Handling of local tasks and procedure management handled by one person on client site.
    • Contact person for HA requests needed.
    • Ability to correspond fluently in local language is crucial.

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ERA for an active substance in antiseptic lozenges

Environmental Risk Assessment accepted by environmental agency; costs manageable

  • Client developed antiseptic lozenges for the treatment of sore throat.
  • Support was needed for compilation of an ERA.
  • Scope of required studies was unclear.
  • High costs for anticipated experimental study set.
  • Scientific Advice meeting at environmental agency required.
  • Contract research laboratories required for experimental work.

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Quality Management System

Client was a large Canadian pharmaceutical company requiring an experienced provider to develop the Quality Management System for their supply chain and distribution office.

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