ING America, Inc. provides consulting services to the life sciences industry in the following areas:

Electronic submissions

• 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.

ICSR

• 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.

Custom Software

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