ING America, Inc. provides a full range of consulting services to the life sciences industry:
- Knowledge management:
- Develop user requirements
- Identify key information repositories
- Analyze integration benefits and risks
- Define exchange mechanisms
- Develop information flow plans
- Establish new business processes
- Records management
- Review current policies
- Regulatory review
- Gap analysis
- Recommendations
- Document management
- Global strategy
- User requirements
- Vendor / product evaluation
- Implementation planning
- Clinical data management
- Global strategy
- Internal standards / SOPs
- Outsourcing guidance
- Vendor / product evaluation
- Electronic submissions
- eCTD submissions to FDA, EU and Japan
- In depth knowledge of specifications and regional guidance
- Conversant with CDISC, SPL and PIM
- 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.