RegAff

Global Regulatory Affairs - Managed

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Our Management Team


Dr. George Butler
Dr. George Butler
CEO is Dr. George Butler, who is well known as a Regulatory Affairs leader in the Pharma Industry and has led Global Regulatory Affairs groups, most recently AstraZeneca and Novartis, is based in USA. more...
Dr. Melvyn Teillol-Foo
Dr. Melvyn Teillol-Foo
Dr. Melvyn Teillol-Foo, who established global bridging activities and supported regulatory in Asia with SmithKline Beecham, Pharmacia and Daiichi Pharmaceutical Company leads the Asia-Pacific group based in Singapore. more...
Dr. Debbie Scholey
Dr Debbie Scholey

Dr. Debbie Scholey FTOPRA, who has 25 years of regulatory affairs experience leading Regulatory Affairs groups in both small and medium sized companies. more...


Our Regulatory Affairs Capability and Experience


Hand-picked Regulatory Affairs specialists with a wealth of hands-on regulatory experience

  • Strategic/Operational
  • NCE/Line extensions/devices/diagnostics
  • Part-dossier/dossier creation
  • Rx/ OTC products
  • Broad geographical reach
  • Access to Health Authority people knowledge: in particular US, EU, Singapore, and Australia
  • All Therapeutic Areas,biologics and small molecules
  • Information management
    • US  Leadership
    • Low cost operational support (eg India)
  • Clinical study analyses and report creation
    • UK Leadership
    • Low plus low cost operational support(eg India)

Alliances

Verinume (www.verinume.com)

  • Information management
  • Secure global document repository
  • Electronic publishing

Kinapse (www.kinapse.com)

  • Clinical study analyses and report writing
  • Country Regulatory Affairs representatives

Regulatory Affairs Resource Network

Functional  Experience level

      CMC      Director level 
   Pre-clinical  Director level
   Clinical    VP/Director level
   Compliance    VP/Director level


Geographical

  • Alliances with small specialist regional regulatory consultants
  • Regulatory networked to greater than 100 independent regulatory consultants throughout the EU

RegAff (c) 2009