Osborne Pharmaconsult

The agency

Osborne-pharmaconsult is an agency for pharmaceutical, biotech and diagnostics companies developing innovative medicines and tests for the benefit of patients. The company can among other things help you create and continue a dialogue with the health authorities on the development plans for a market authorisation of your new medicine.

My services

• Business Plans
• Global regulatory management
& operations
• General Development advice
• Support to SMEs
• Scientific advice
• Special Protocol Assistance
• Meetings with FDA
• Orphan drug designations
• Risk management plans

Anita Osborne

Anita Osborne

MBA, MSc Pharm

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Regulatory consultant life science

For 19 years I have worked with Regulatory Affairs at Novo, Roche, Leo-Pharma, Danish biotech and Dako (diagnostics). I have a broad knowledge on Regulatory affairs development, maintenance of the business licenses and also management in a Global organisation. My strenght is Regulatory strategies and Development of Innovative medicines, Personalised Medicine and Diagnostics. I have extensive experience working with the European Medicines Agency with orphan drugs, scientific advice and also the "preauthorisation unit" in getting Innovative Medicines approved since 1995. I have taken products through early development to Marketing Authorisation in Europe and the US. Have prepared and held many important meetings negotiating with the FDA and other important health authorities on drugs as well as diagnostics. I have and have had Global leadership with employees in China, Japan, US, Denmark, Middle East and GCC and have an understanding of what it takes to get world wide market access and building an efficient organisation, partner and CRO management. I have also supported companies in making Business and Development Plans and meetings regarding funding. I am a member of Danish Biotech and am mentor for start-ups from the university in Copenhagen.

Consultant for Life Science

  • Regulatory Business Partner, LaMEA

    Leo-Pharma A/S · September 2013 -
  • Global Regulatory Director

    Dako · july 2009 - february 2013
  • Director of Regulatory Affairs and Project management

    Rheoscience A/S · 2006 – 2008
  • Project Director Regulatory affairs

    Novo Nordisk A/S · 2003 – 2006
  • Global Regulatory Leader

    Hoffmann-La Roche · 2000 – 2003
  • Regulatory project manager

    Novo Nordisk A/S · 1995 – 2000

Osborne Pharmaconsult

  • Vesterhavnen 15, 3
    5800 Nyborg
    Denmark
  • +45 2249 4004
  • Mail
Osboene Molekyle