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Tailored medical
affairs

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Unlocking markets to transform patient outcomes

Our end-to-end medical affairs services, coupled with our in-depth local knowledge, remove barriers to launch in European markets, increasing access for both providers and patients.

We leverage our extensive therapy area expertise, local and global launch experience to deliver medical affairs strategies tailored to your market.

Full spectrum services

Supporting you from discovery to launch and beyond

Evidence

Education

Engagement

Core services

$

Strategy and consulting

  • Launch strategy tailored to European markets
  • Bespoke local strategy and tactical planning
  • Local brand team medical support
$

Stakeholder engagement

  • Global activity
  • Advisory boards
  • Medical symposia
$

Evidence generation and outcome research

    • Clinical evidence gap analysis
    • Development of integrated RWE plan
    • Abstract and manuscript publication
$

In-field excellence

  • HCP engagement and insights generation
  • Hospital and 1:1 presentations
  • Digital engagement
  • In-field MSLs
$

Medical education and scientific training

  • Medical symposia
  • Speaker meetings
  • Disease area education
  • Product training
  • Congress review
  • Webinars
  • Podcasts
$

Patient support

  • Medical information service
  • Patient support programmes
  • Patient advocacy group engagement

Strategy and consulting

  • Launch strategy tailored to European markets
  • Bespoke local strategy and tactical planning
  • Local brand team medical support

Stakeholder engagement

  • Global activity
  • Advisory boards
  • Medical symposia

Evidence generation and outcome research

  • Clinical evidence gap analysis
  • Development of integrated RWE plan
  • Abstract and manuscript publication

In-field excellence

  • HCP engagement and insights generation
  • Hospital and 1:1 presentations
  • Digital engagement
  • In-field MSLs

Medical education and scientific training

  • Medical symposia
  • Speaker meetings
  • Disease area education
  • Product training
  • Congress review
  • Webinars
  • Podcasts

Patient support

  • Medical information service
  • Patient support programmes
  • Patient advocacy group engagement

Robust QMS

Our established QMS platform meets all regulatory and quality assurance needs. The platform offers global regulatory operations support, regulatory affairs and global pharmacovigilance.

Regulatory applications and submissions

  • Marketing authorisation application
  • Lifecycle management
  • Marketing authorisation transfers
  • CMC and medical writing
Regulatory operations
  • Dossier publishing
  • Artwork and labelling
  • Linguistic review and translations
  • Regulatory intelligence

Pharmacovigilance

  • Pharmacovigilance QMS
  • QPPV services
  • Responsible person services
  • ICSR & SAE management
  • Post-marketing local PV case processing management
  • Periodic safety update reports and signal detection
  • Local and global literature review
  • Quality review
  • Risk management plans
Medical information
  • Process medical inquiries from HCPs, patients and caregivers
  • Identification and documentation of AE and PQCs
  • Medical writing
  • FAQs
  • Standard response letters and customised responses
Compliance
  • Observes the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • Full review and sign-off of promotional and non-promotional materials
  • National transparency reporting

Find out how our in-depth local knowledge can help remove barriers to launch your therapy and transform outcomes for patients.