Submission Management Automation (eCTD)

It's a complex world pharmaceutical companies operate in. While selling in multiple Countries represents opportunities for drugmakers to offer medications to broader patient populations, each market comes with a unique set of regulatory challenges to overcome before drugs can be prescribed there.

For a pharmaceutical company looking to extend the lifecycle of a drug, navigating the varying multi-country submissions requirements can be daunting—and costly if not done in an efficient and compliant manner. For every day a drug launch is delayed due to rework, the losses equate to approximately $1.1 million daily in prescription revenue.

To help pharmaceutical companies successfully launch or expand therapies into new markets, integrated solutions with the functionality to create any submission format (eCTD, NeeS, ACTD and paper) as well as comply with evolving country-specific guidelines and a central platform for global collaboration on all data and documentation during the submissions process are required, in order to attain reductions in the submissions cycle and time-to-market.

Since ICH's announcement on the Common Technical Document (CTD) agreement in November 2000, a new set of regulatory compliance requirements were imposed on manufacturers of life sciences products. This is particularly evident in the reduction of the time between drug approval submissions and their approvals. For manufacturers with understaffed regulatory departments, attempting to implement electronic CTD (eCTD) and electronic submission (eSubmission) applications while simultaneously undergoing product approval, this is particularly burdensome.

This situation is exacerbated by the FDA's recommendation to life sciences manufacturers to utilize "eSubmitted eCTDs" that adhere to international formatting standards.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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