Exostar Cited by FDA as Proven Digital Certificate Provider as May 5th Compliance Deadline Looms

Mandate Requires Electronic Submission of Drug Master Files Using Trusted Digital Certificates

HERNDON, Va.--()--Exostar, whose cloud-based solutions help companies in aerospace and defense, life sciences, and healthcare collaborate securely with their partners, today announced its recognition by the Food and Drug Administration (FDA) as a proven provider of digital certificates that validate the authenticity of electronic documents and their owners. Digital certificates are poised to become a top priority for life sciences organizations, given a pending deadline issued by the FDA.

Starting May 5th, the FDA will require all drug master file submissions to be in Electronic Common Technical Document (eCTD) format to bring consistency and efficiency to the drug review and approval process. In addition, eCTD-based communications between life sciences organizations and the agency will have to take place via the FDA’s Electronic Submissions Gateway (ESG). The ESG is a secure exchange point for the FDA and its partners to interact. However, only individuals possessing trusted digital certificates will be able to use the ESG successfully.

Life sciences organizations face a choice. They can devote the time and resources necessary to create their own Certificate Authority (CA) to issue and maintain digital certificates for their employees and those of their partners needing to engage the FDA’s ESG. Or, they can turn to a trusted third-party CA like Exostar.

Exostar offers more than a decade of experience as a full lifecycle provider of public key infrastructure (PKI) based digital certificate solutions. The company has issued over 150,000 PKI certificates, and its solutions are cross-certified with the SAFE-BioPharma Certificate Authority and the Federal Bridge Certification Authority.

“The FDA’s pending deadline represents a milestone that will bring significant long-term benefits to the agency, the life sciences industry, and consumers. It also reflects a commitment to better securing intellectual property and personally identifiable information,” said Matthew Williams, Exostar’s Product Manager of Identity and Access Management Solutions. “We can help life sciences organizations comply without losing focus on their drug development missions. With a track record that includes a leading identity management role for TransCelerate BioPharma, as well as the issuance and maintenance of over 200,000 credentials for more than 3,000 life sciences organizations worldwide, Exostar is the de-facto identity provider for the life sciences market.”

About Exostar

Exostar, named a Cool Vendor for 2016 by Gartner, offers cloud-based solutions that help companies in highly-regulated industries mitigate risk and solve identity and access challenges. Nearly 150,000 organizations leverage Exostar to help them collaborate securely, efficiently, and compliantly with their partners and suppliers. By offering connect-once, single sign-on access, Exostar strengthens security, reduces expenditures, and raises productivity so customers can better meet contractual, regulatory, and time-to-market objectives. www.exostar.com.

Contacts

Exostar
Alan Gilbert
703-793-7735 (o)
703-624-4675 (m)
Alan.Gilbert@exostar.com

Release Summary

Starting May 5, FDA requires electronic submission of drug master files using trusted digital certificates. FDA cites Exostar as proven provider.

Contacts

Exostar
Alan Gilbert
703-793-7735 (o)
703-624-4675 (m)
Alan.Gilbert@exostar.com