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Synteract Uses Same Platform as FDA for eCTD Submissions for Clients

Synteract Uses Same Platform as FDA for eCTD Submissions for Clients
16 February 2017

Synteract has been working with Electronic Common Technical Document (eCTD) software for a long time. The eCTD is CDER/CBER’s standard format for electronic regulatory submissions and already the preferred format to help simplify life cycle management and sharing of regulatory information for many International Regulatory Authorities. It has been required for medicinal products submitted to the EMA since 2009. And it will become the required standard by the FDA for NDAs (New Drug Applications), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) in May 2017 and IND (Investigational New Drug) applications in May 2018.

Recently, the FDA announced it was awarding LORENZ with an “Electronic Common Technical Document Validation and Review Software” contract and that it would use LORENZ technology in CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) programs to validate and review incoming and legacy eCTD submissions. The U.S. joins 11 regulatory agencies already using LORENZ, including those of Australia, Austria, Canada, Czech Republic, European Union, Germany, Ireland, Montenegro, Poland, Slovenia, Thailand, and more than 400 customers using its e-Regulatory systems.

Synteract also uses LORENZ, as an industry standard, to compile, publish, manage and review eCTD submissions for our sponsors. The benefits to Synteract clients of being on the same system being used by the FDA include the following, according to Thomas Christensen, senior regulatory affairs manager at Synteract:

Greater transparency – With LORENZ managing both the technologies for the FDA (to validate and review submissions), and for CROs and sponsors (to submit to the FDA), all parties will see the same screens and information that the FDA sees, enabling easier access to information.

Potential for smoother updates – LORENZ will be able to leverage knowledge and experience working with the FDA in its system for CROs and sponsors to potentially enable smoother updates across all of its platforms.

Harmonization with global agencies – In using LORENZ, the FDA will be on the same platform as other international regulatory agencies. LORENZ’s docuBridge® complies with all global eCTD standards and with many regulatory agencies globally using it for reviewing. Being on the same system may help to make future initiatives to work together seamlessly, such as with eCTD 4.0 RPS (Regulated Product Submissions) standards, to enable two-way communication between the FDA and sponsored companies within the publishing system.

“As a company that stays at the forefront of electronic document preparation, submission management and regulatory authority submission, we are proud to use LORENZ docuBridge as the FDA standard. For companies preparing to start investigational trials or MAA submission, we can help to ensure quality, accuracy and international standards across multiple-country submissions, from Pre-IND meetings requests through Annual New Drug Approval reports or Ad/Promo submissions and more,” says Christensen.

To learn more about how Synteract can help with multiple-country eCTD submissions, make it easier to share information internally and externally, and convert current paper submission documents to electronic format, contact Thomas Christensen at Thomas.Christensen@Synteract.com.

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