Liquent Announces FDA Submission of Full Electronic Technical Document-eCTD-NDA Utilizing CoreDossier Publishing Solution
Liquent, Inc. the global leader in providing regulatory software solutions, information products, and related services for the life sciences industry, announced today that Dow Pharmaceutical Sciences successfully submitted a full Electronic Common Technical Document (eCTD) submission to the FDA. Utilizing Liquent’s CoreDossier(R) publishing solution, Dow in conjunction with Liquent’s Consulting Services Organization submitted one of the first eCTD’s to the FDA’s Division of Dermatologic Drugs. This milestone supports a trend in providing regulatory agencies with submissions in electronic format, which can result in a more efficient review process.
“The importance of submitting the full eCTD to the FDA is in line with Dow’s regulatory strategy to help products reach the market faster and more cost effectively,” said Barry Calvarese, Vice President Regulatory and Clinical Affairs. “Liquent’s Consulting Services and CoreDossier, coupled with our own in-depth electronic NDA expertise, helped us achieve our goal of demonstrating the benefits of the eCTD.”
“Dow Pharmaceutical Sciences needed a strategic partner with the expertise and innovative solutions to help them achieve their goals for an eCTD submission,” said Jay Nadler, CEO of Liquent. “Currently one of the biggest challenges with eCTD submissions is understanding not only what is technically required to provide a compliant eCTD, but also having the subject matter expertise to be able to interpret what agency reviewers want and need in this new type of submission. Liquent is pleased that our clients can easily produce the XML backbone and regional XML files. We look forward to helping them address the eCTD’s added challenges of submission lifecycle management with the launch of InSight Manager for Assemblies this coming December.”
Liquent is the world’s largest regulatory solutions vendor and the recognized leader in the field, having supported the first-ever complete CTD submission in the EMEA, eCTD submissions to the FDA, and multiple-authority eCTD submissions. In addition, Liquent’s consulting, regulatory and product management teams are working with many life sciences organizations of all sizes to provide eCTD expertise based on a combined knowledge base of over 5,000 regulatory submissions.
About Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences specializes in the development of dermatology and other topical products for pharmaceutical and biotechnology clients. They develop and optimize formulations with the help of their Skin Biology and Drug Delivery Laboratory. Dow also provides regulatory strategy development, non-clinical and clinical study design and management, and regulatory filings required to take dermatology products through FDA approval.
About Liquent, Inc.
Liquent’s software and service offerings help ensure clients meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time. In addition to technology and services, Liquent’s IDRAC database service provides the most comprehensive intelligence on the drug and biologics regulatory environment in 38 of the largest markets in the world.
As a result, 48 of the top 50 global life sciences companies rely on Liquent to stay current with the latest intelligence and to provide the technology and services to compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity, all of which contribute to ensuring patients’ and physicians’ timely access to new drugs. Over the last decade, more than 5,000 regulatory submissions have been produced using Liquent’s world-class products and expert services.
Liquent’s headquarters are located in Horsham, Pennsylvania and its European headquarters reside in Chippenham, UK. Liquent has additional offices in Paris, France; Brunnthal, Germany; and Tokyo, Japan. www.liquent.com
Liquent is a wholly owned subsidiary of Information Holdings Inc. (NYSE: IHI).
About Information Holdings, Inc.
Information Holdings Inc. is a leading provider of information products and services to intellectual property and life science markets. IHI’s data businesses, which include MicroPatent(R), Master Data Center(TM) and IDRAC, provide a broad array of databases, information products and complementary services for intellectual property and regulatory professionals. IHI’s Liquent unit is a leading provider of life science regulatory intelligence and publishing solutions.
