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Solution includes assistance with submitting regulatory submissions.
LexisNexis Reed Tech, a provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to offer end-to-end electronic common technical document (eCTD) solutions and services to support manufacturers, distributors, and related operations. The eCTD service expansion, says Reed Tech, provides a solution for compiling, formatting, and submitting regulatory submissions in electronic, compliant format.
The company will support pharma companies, contract research organizations (CROs), and other stakeholders in preparing regulatory submissions, including investigational new drug application (IND), new drug application (NDA), abbreviated new drug applications (ANDA), biologics license application (BLA), and more.
"Our goal is to simplify the regulatory submission process for our clients by providing expert eCTD submission publishing services that ensure compliance, accuracy, and timeliness,” notes Wendy Scott, head of life sciences professional services at Reed Tech. " … This new service will offer a more complete regulatory solution for our 1,000+ current SPL pharma customers, as well as potential new customers, in one place, increasing efficiency while managing the product regulatory approval process."