• Years of experience implementing submission publishing and electronic document management systems (EDMS) in the life sciences regulatory environment.

  • Vendor-neutral on all components of a total solution.

  • Expert in technologies, practical techniques and processes for producing paper and electronic submissions for pharmaceutical, biotechnology, and medical device industries

  • Expert in current and emerging requirements for information technology, regulatory affairs, and regulatory operations.

  • Implemented systems, processes, and standards to support paper and electronic submissions for FDA, EU, Canada, and other health authorities around the world.

  • Fully covered with business and professional errors and omissions liability insurance.