ING America, Inc. provides consulting services to the life sciences industry in the following areas:
eCTD submissions to FDA, EU and Japan
In depth knowledge of specifications and regional guidance
Conversant with CDISC, SPL and EVMPD
eCTD Readiness Assessment
Broad knowledge of marketed eCTD software products
Developed software tools for eCTD creation, review, viewing and validation.
In depth knowledge of specifications and regional requirements and implementation (US, EU and Japan).
Developed custom software for ICSR reporting
21 CFR Part 11 – strategy, general approach, SOP development and other related policy development such as records management and security.
Together with our sister company, ING Corporation, Tokyo, we provide custom software development and implementation in support of pharmaceutical R&D and Regulatory activities in North America and Japan