Navigation Links
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
'/>"/>

SOURCE Cardinal Health
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Cardinal Health Releases New Tool to Combat MRSA Infections in Hospitals
2. Stem Cell Breakthrough Advances Science Without Ethical Landmines, Says Cardinal
3. Hydrox Inc., Cardinal Health Issue Nationwide Recall of Alcohol-Free Mouthwash For Hospitals
4. Cardinal Health Completes Enturia Acquisition
5. Cardinal Health Expands PET Nuclear Pharmacy Services to Support Clinical Drug Trials
6. AmeriCares Honors Cardinal Health with Power of Partnership Award
7. Cardinal Health Helps Hospitals Save More Than $20 Million In Pharmaceutical Costs; Connect Low-Income Patients With Affordable Medications
8. Cardinal Health Executives to Speak at Two Investor Events in January
9. Cardinal Health Names Carrie Cox to Board of Directors
10. Cardinal Health Raises Quarterly Dividend By 11 Percent
11. Cardinal Health Supports ACRIN Clinical Trials Evaluating Oncologic Biotracers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... DIEGO , Dec. 23, 2014 ResMed (NYSE: ... significant patent infringement action against Chinese medical device manufacturer BMC ... (ITC) ruled today that BMC,s masks listed below infringe ResMed,s ... or selling these masks in the United States ... iVolve N2 nasal mask , Willow nasal pillows mask ...
(Date:12/24/2014)...  The American Diabetes Association is recommending a ... with diabetes and that all people with diabetes ... in keeping with recent changes to guidelines for ... of Cardiology (ACC) and American Heart Association (AHA). ... changes to the Association,s annual revised Standards of ...
(Date:12/22/2014)... Dec. 22, 2014  CytoSorbents Corporation (OTCQB:CTSOD), a ... blood purification technology to help fight deadly inflammation ... countries worldwide, today announced the appointment of Dr. ... as its Senior Vice President of Clinical Development, ... Di Russo is an accomplished pediatric ...
Breaking Medicine Technology:ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 2New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 3New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 5
... June 1 DURECT Corporation (Nasdaq: DRRX ) announced today that ... the Jefferies Global Life Sciences Conference on Thursday, June 10 at ... Hotel in New York .   , ...   http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO ) , , , ...
... , June 1 Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ ) ... Officer, will present at the Jefferies 2010 Global Life Sciences Conference on ... the Grand Hyatt Hotel in New York, NY . , ... A live webcast of the presentation may be accessed ...
Cached Medicine Technology:DURECT to Present at the Jefferies Global Life Sciences Conference 2
(Date:12/25/2014)... Recently, LunaDress.co.uk has updated its blog to provide professional ... all of the models at LunaDress.co.uk come with big discounts, up ... wedding veil can turn out to be a most exciting memory ... can always bring surprise to a wedding. On the updated fashion ... choose veils for a big day . , Going out with ...
(Date:12/25/2014)... THURSDAY, Dec. 25, 2014 (HealthDay News) -- Overeating is common ... you eat in moderation, an expert says. "Don,t arrive ... up calories if you know you,ll be attending a party, ... Jill Ashbey-Pejoves, lead dietitian at Northern Westchester Hospital in Mount ... better to eat healthy during the day and even to ...
(Date:12/25/2014)... AngelWeddingDress.com tries its best to translate the experience ... business has introduced its new collection of 2015 prom ... The new prom outfits are guaranteed to contain the ... are specially designed for 2015. Anyone who wants to ... its website before Jan. 26, 2015, the deadline of ...
(Date:12/25/2014)... California (PRWEB) December 25, 2014 Plugin ... of ProFire 5k. A fully customizable business presentation tool ... , “Adding the ProFire 5k business tool, users can ... Christina Austin, CEO of Pixel Film Studios. “ProFire 5k ... and style to add professionalism to a presentation” , ...
(Date:12/25/2014)... Parker & Sons, Inc. an industry leader ... quality regarding heating, cooling and plumbing services in the ... the “Queen of Clean” for impressive contractor services in ... over the years for providing outstanding quality customer service ... services for both homeowners and businesses. Linda Cobb, known ...
Breaking Medicine News(10 mins):Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Angelweddingdress 2015 Prom Dresses Online Now 2Health News:Announcing a new ProFire 5k plugin from Pixel Film Studios for Final Cut Pro X Professionals 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 3
... the PSA test is a far from perfect tool , , ... conflicting views on the value of screening men with a ... But at least one leading oncologist says this much seems ... history of prostate cancer should pay attention to a PSA ...
... 3 cosmetic surgery procedures in 2008 according to a recent survey conducted ... New Jersey plastic surgeon , Dr. Paul Parker, contributed to the ... ... 2009 -- Dr. Paul Parker, a board certified New Jersey cosmetic ...
... March 18 Managed Health Care Associates, Inc. (MHA) ... Term Care Member Study, the results of which will ... 19-20, 2009 in Las Vegas, Nevada.The inaugural study was ... members, business partners and industry insiders. As a ...
... has found a link between physical and mental ... to capitalize on to improve both the health, ... these turbulent economic times. , Thomas A. Wright, ... professor of management at K-State, published his findings ...
... poorer health for many older adults, those who also ... the University of Chicago suggests. Older people who are ... same health problems. , The study is the ... different types of isolation. Researchers measured the degree to ...
... Even during the economic downturn, it is vital not ... is covered by insurance and can save money in ... research studies from the Mayo Clinic are confirming the ... prenatal physical therapy, which targets specific pregnancy issues vs. ...
Cached Medicine News:Health News:2 Studies Conflict Over Value of Prostate Cancer Screening 2Health News:2 Studies Conflict Over Value of Prostate Cancer Screening 3Health News:New Jersey Plastic Surgeon Helps Determine Top Cosmetic Surgery Procedures of 2008 2Health News:New Jersey Plastic Surgeon Helps Determine Top Cosmetic Surgery Procedures of 2008 3Health News:MHA to Release Results of Second Annual Independent Long Term Care Member Study 2Health News:Employee cardiovascular health relates to psychological well-being 2Health News:Employee cardiovascular health relates to psychological well-being 3Health News:Few friends combined with loneliness linked to poor mental and physical health for elderly 2Health News:Few friends combined with loneliness linked to poor mental and physical health for elderly 3Health News:Proactive, Low-Cost Prenatal Physical Therapy Reduces Pregnancy Complications, Eases Labor and Delivery and Shortens Recovery Time for Mothers 2Health News:Proactive, Low-Cost Prenatal Physical Therapy Reduces Pregnancy Complications, Eases Labor and Delivery and Shortens Recovery Time for Mothers 3Health News:Proactive, Low-Cost Prenatal Physical Therapy Reduces Pregnancy Complications, Eases Labor and Delivery and Shortens Recovery Time for Mothers 4
... Premier Encore's balanced, iso-centered c-arm ... device is easy to position ... Controls on the x-ray tube ... and wireless remote control provide ...
... from Medennium is an innovative device ... tear duct, and conserve the eye's ... fit a range of punctum sizes. ... material, SmartPLUG adjusts to the exact ...
Khosla Precision and Quality in Medical and Surgical Products....
Khosla Precision and Quality in Medical and Surgical Products....
Medicine Products: