Articles
HollisterStier Contract Manufacturing Regulatory Affairs Expands Electronic Submission Technology
January 7, 2010
The Regulatory Affairs department at HollisterStier Contract Manufacturing announced recently the recent implementation of new electronic submission software, Datafarm's S-cubed eCTD. HollisterStier installed and validated the software for use in assembling IND, NDA, or BLA electronic submissions. This would include drug product information supplied by HollisterStier, along with the clients' submission ready drug substance, clinical and non-clinical data. This technology is required by FDA and various international regulatory agencies for electronic filings.
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.
"HollisterStier takes great pride in our Regulatory standing and the expertise of our staff— our electronic submission capabilities are one way that we ensure we are compliant, timely and in-touch with the latest innovations in the industry. This will also further our ability to service our clients." said Marcelo Morales, CEO HollisterStier Laboratories - Draxis Pharma.
About HollisterStier Contract Manufacturing
HollisterStier Contract Manufacturing is a global manufacturing service provider, able to aseptically fill liquid and lyophilized products at our Spokane, Washington facility and semi-solid and solid dosage forms at our sister organizations located in Canada, the United States and India. HollisterStier Contract Manufacturing offers highly-skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. Along with our manufacturing partners, we are committed to providing exceptional quality, regulatory expertise and operational excellence to ensure streamlined processes and services in all facilities. For more information visit HScontract.com.
