HORSHAM, Pa., February 14, 2023 /PRNewswire/
LexisNexis Reed Tech has teamed up with ONIX, a boutique regulatory affairs and operations consultancy, supporting global eCTD submissions.
Professionals in the life sciences industry rely on unique regulatory affairs expertise to effectively manage the full end-to-end Electronic Common Technical Document (eCTD) process. Reed Tech, a leading provider of data management and analytics solutions for the life sciences industry, continues to build an alliance of world-class solution providers, a collective of regulatory experts delivering solutions and services who support manufacturers, distributors and related operations. To strengthen the breadth of pharma eCTD submission solutions, Reed Tech has expanded its collaboration with ONIX, a leading industry expert, serving specialized regulatory processes for clinical trial and drug applications. Current and prospective customers of both companies can leverage exclusive benefits as part of this new strategic alliance.
“ONIX has a world-class track record of servicing clients globally with eCTD services that carry a 100% approval rate with zero eCTD technical rejections since their inception in 2010. The Structured Product Labeling (SPL) expertise of Reed Tech aligned with the global regulatory operations and consulting services provided by ONIX, offer a more streamlined process to support our pharma customers” said Arshad Rahman, General Manager of the Reed Tech Life Sciences division.
“Reed Tech is the industry leading SPL services provider servicing 1,000+ pharma customers around the world, large and small. Their decades of experience delivering quality files on-time and accurately has garnered Reed Tech a stellar reputation and positioned them as an industry leader in the Life Sciences community. Our customers can undoubtedly benefit from the expertise and guidance provided by their dedicated team of technical specialists in understanding global regulatory submission requirements,” said Jasbir Chohan, CEO of ONIX. “As a result, ONIX is delighted to partner with Reed Tech to offer a comprehensive solution that helps pharma companies bring new products to market and maintain existing portfolios.”
Pharma manufacturers and labelers have obligations to regulators requiring expertise to ensure approvals and speed to market. The complementary solutions and services between Reed Tech and ONIX offer critical efficiency gains in managing the product regulatory approval process.
About LexisNexis Legal & Professional LexisNexis
LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.
Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission, and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. For more information, please visit ReedTech.com.
About ONIX
ONIX is a global regulatory operations and advice consulting group. The team has over 60 years of experience in supporting Pharma, Biotech, Universities, Contract Research Organization (CRO) and Pharma Venture Capital companies throughout the regulatory approval processes for drugs, herbal, veterinary and medical devices with their respective Regulatory Health Authorities. ONIX has supported more than 100 clients across Europe, North America, South America, Middle East and Asia Pacific throughout the process from initial clinical trials application to full marketing approvals and lifecycle maintenance. For more information, visit www.onixls.com.