RegCheck provides the tools for regulatory and technical review of nonclinical
and clinical documents.
The 24 checklists contain over 2,000 study specific elements that are required to be present
or addressed according to the most current FDA guidance documents.
The checklist elements are annotated
and linked to 21 CFR and ICH, FDA and OECD guidelines, with over 6,700 citations. These on-line reference
links are easily accessible to the user and facilitates knowledge transfer to contract personnel or even
more junior staff.
See the RegCheck website for details: http://myregcheck.com