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Cardinal Health Specialty Solutions Submits 1,000th Electronic Common Technical Document (eCTD) to FDA
Date:3/21/2012

DUBLIN, Ohio, March 21, 2012 /PRNewswire/ -- The Scientific and Regulatory Consulting Services business of Cardinal Health Specialty Solutions, previously known as Beckloff Associates, announced today that over the past five years it has submitted 1,000 electronic Common Technical Documents (eCTDs) to the U.S. Food and Drug Administration (FDA) on behalf of more than 200 clients, worldwide.

Since its introduction in 2003, the eCTD has rapidly become the format of choice for drug and biologic applications, including New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) reviewed by FDA; and for marketing applications reviewed by other global health authorities. eCTDs help accelerate the approval process for bringing new pharmaceutical products to market, and can improve the overall costs of drug development.

"For more than 35 years, we have been helping pharmaceutical and biotech companies speed product development, approval and post-approval," said Michael Beckloff, vice president and general manager, Scientific and Regulatory Consulting Services for Cardinal Health Specialty Solutions. "Reaching this milestone – publishing 1,000 eCTDs – demonstrates our proven success in delivering high-value regulatory publishing and consulting services to clients with drug and biologic products at all stages of development and approval."

According to Beckloff, Cardinal Health Specialty Solutions' extensive team of veteran scientific and regulatory consultants and publishing professionals, its ability to operate multiple eCTD publishing hardware and software platforms and its adaptability are three of the main strengths that have enabled his team to reach this milestone. The team's approach eliminates the need for software and hardware investment and provides immediate, flexible and responsive publishing capacity.

"Cardinal Health Specialty Solutions has provided publishing and critical scientific and regulatory
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SOURCE Cardinal Health
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