30 Sep, 2009 – Datafarm™, a world leading provider of high performance electronic regulatory submission solutions for the life sciences industry, announced on 30 September 2009 that HollisterStier Contract Manufacturing installed and validated S-Cubed® eCTD to manage and compile electronic regulatory submissions for the FDA. This would include drug product information supplied by HollisterStier, along with the clients’ submission-ready drug substance, clinical and non-clinical data.

HollisterStier’s Regulatory Affairs department adds this software to their existing electronic capability which includes assisting clients in the creation of an FDA Electronic Submission Gateway (ESG) account at client sites for direct submission of electronic information to the FDA. Additionally, HollisterStier can perform electronic establishment registration and electronic drug listing using Structured Product Labeling (SPL) eXtensible Markup Language (XML) functions for clients or train clients’ staff to perform these functions. HollisterStier’s electronic submission offerings provide a comprehensive set of regulatory support options under the same roof as fill/finish operations.

About S-Cubed eCTD

Datafarm’s S-Cubed® eCTD includes all of the latest global regulatory agency requirements so that users can quickly create consistent and compliant eCTD submissions. S-Cubed eCTD enables complete lifecycle management of the eCTD allowing users to publish, compile, review, validate and track all content throughout the entire drug development process. S-Cubed® eCTD conforms to the current ICH and
regional requirements for delivering eCTD submissions to the US, EU, Canada, Japan, and Taiwan regulatory agencies. For more information about S-Cubed eCTD, click here.