Capabilities

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.