Cardinal Health Specialty Solutions Submits 1,000th Electronic Common Technical Document (eCTD) to FDA

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Mar 21, 2012, 09:00 ET

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 work for our NDA, from the original submission in late 2010 through approval, and now they're also supporting our post-approval submissions," said Douglas Saltel, president and CEO of Edgemont Pharmaceuticals. "We have placed a great deal of trust in them and they continue to deliver the right solutions for us."

Cardinal Health Specialty Solutions partners with each client to understand their desired regulatory outcomes, and then applies its expert knowledge to reach those outcomes, enabling clients to focus their time and attention on other critical aspects of the approval process.

"From the publishing of our original Investigational New Drug (IND) in 2010, through many IND amendments, and in the planning and preparation of our NDA submission, we have tested Cardinal Health Specialty Solutions' ability to accommodate tight timeframes and to respond to our business priorities," said Jerry Wisler, CEO of Omthera Pharmaceuticals. "They have consistently published with efficiency and without quality compromises."

About Cardinal Health Specialty Solutions

Cardinal Health Specialty Solutions provides regulatory, clinical, reimbursement, technology and distribution services to help health care professionals, payors and pharmaceutical and biotech companies improve the quality and cost-effectiveness of caring for patients who are managing complex diseases. Cardinal Health Specialty Solutions partners with customers to alleviate day-to-day administrative burdens, optimize business functions and to implement new innovations that move their businesses forward. To learn more, visit www.cardinalhealth.com/specialtysolutions.

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #19 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com and @CardinalHealth on Twitter.