SlideShare a Scribd company logo
Speid & Associates, Inc. Consultancy Services, Inc. Lorna Speid, Ph.D., RAC President Speeding New Drugs to Market ® www.drugstomarket.com
Staff at Speid & Associates ,[object Object],[object Object],[object Object]
Staff at Speid & Associates ,[object Object],[object Object],[object Object]
Dr. Speid – Credentials  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dr. Speid – Expertise ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dr. Speid – Expertise ,[object Object],[object Object],[object Object],[object Object]
Speid & Assoc. Associates ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How We Work ,[object Object],[object Object],[object Object],[object Object],[object Object]
How We Work We believe that a successful development program requires more than serendipity or luck --- We have a proven track record of past achievements
How We Work It is very easy to throw money away if you do not have the right people on your team --- We are experienced in working with diverse teams  -- We will ensure that the knowledge remains within the client company by working closely with the team
How We Work We work with our clients to achieve successful global registration, as expeditiously as possible  --- we identify the pieces of the jigsaw and help the client to work out how they fit together
How We Work ,[object Object],[object Object],[object Object],[object Object]
How We Work We can help you to determine what your next move should be in the drug/device/diagnostic or combination development program
How We Work – the Starting Point Review of Regulations US Europe International Review of Guidelines US Europe International Review of ICH guidelines Development of global and US regulatory and development strategy
Overview of Services - Customer Base ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services – Due Diligence ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services - Clinical ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services - INDs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services – Clinical Trial Applications ,[object Object],[object Object],[object Object],[object Object]
Overview of Services – Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services – Applications and Reports ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services – eCTD Services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Overview of Services – Company Staff Development ,[object Object],[object Object],[object Object],[object Object]
Partnerships ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Webinar Series ,[object Object],[object Object],[object Object],[object Object]
Webinar Series ,[object Object],[object Object],[object Object]

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Company Presentation Final June 2008

  • 1. Speid & Associates, Inc. Consultancy Services, Inc. Lorna Speid, Ph.D., RAC President Speeding New Drugs to Market ® www.drugstomarket.com
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9. How We Work We believe that a successful development program requires more than serendipity or luck --- We have a proven track record of past achievements
  • 10. How We Work It is very easy to throw money away if you do not have the right people on your team --- We are experienced in working with diverse teams -- We will ensure that the knowledge remains within the client company by working closely with the team
  • 11. How We Work We work with our clients to achieve successful global registration, as expeditiously as possible --- we identify the pieces of the jigsaw and help the client to work out how they fit together
  • 12.
  • 13. How We Work We can help you to determine what your next move should be in the drug/device/diagnostic or combination development program
  • 14. How We Work – the Starting Point Review of Regulations US Europe International Review of Guidelines US Europe International Review of ICH guidelines Development of global and US regulatory and development strategy
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.

Editor's Notes

  1. 39