Outsourcing: A Rapid, Cost-Effective Option For Electronic Submissions

By Beckloff Associates, Inc.

Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic format for their marketing applications to FDA. The decision to adopt the electronic Common Technical Document (eCTD) submission format is a strategic one, offering the sponsor these important benefits:

1. a greatly enhanced ability to efficiently organize, prepare, and manage submission content
2. the opportunity for streamlined interactions with agency reviewers,
3. a potentially more efficient and thorough agency review.

Barriers to adoption typically include:

1. costs (initial capital: $200K- $300K and annual expense: $100 - $200K) of building, validating and operating an electronic publishing system,
2. effort and time to learn and understand the regulatory requirements and to develop the organizational competency to efficiently produce compliant eCTD submissions.