SUBMISSION EXPERT
GLOBAL SUBMISSION MANAGEMENT SOLUTIONS
Global life sciences companies are increasingly adopting the CTD as the preferred format for global dossiers. The International Conference on Harmonization (ICH) has established an acceptable format for the electronic Common Technical Document (eCTD) to facilitate the delivery of dossiers to global agencies in a uniform manner. In the EU, eCTD is accepted in number of countries. From 2009 it will become mandatory format in the EU. The U.S. has indicated that the eCTD is their preferred format beginning January 1, 2008., but at the same time, there is a number of countries still accepting dossiers in region or country specific format.
To develop a fully electronic dossier based on the eCTD, or any other, region or country specific format, requires a comprehensive strategy and integrated technologies to ensure success. These technologies include:
- Enterprise Content Management
- Quality Assurance and Quality Control
- Input/Capture Technologies
- Electronic (PDF and/or eCTD) Publishing
- Content Transformation
- Storage Technologies
- Integrated Messaging
- Comprehensive Interdepartmental Collaboration
Infotehna’s SubmissionExpert™ - The RIGHT Choice
SubmissionExpert™ is a comprehensive solution that leverages Infotehna’s own compliance process control engine coupled with EMC/Documentum’s flagship content management technology. The solution delivers regulatory document control in accordance with cGMP and GAMP guidelines. In addition to its comprehensive document lifecycle workflow, cGMP change control, security model, audit trails, digital/electronic signature capability, version control, SubmissionExpert™ includes an integrated input/capture and publishing capability for document rendering, PDF and eCTD publishing, and eCTD XML generation. The system is fully compliant with 21 CFR Part 11 guidelines for closed systems and is validation ready. SubmissionExpert™ delivers a total solution for regulatory affairs organizations.
Rapid Deployment and On Demand Technical Support
In support of SubmissionExpert™ Infotehna provides comprehensive on demand services and technical support to ensure rapid deployment and system adoption. All Infotehna lifesciences solutions are deployed in validated systems environments, thus we offer validation (IQ/OQ/PQ) protocols to support validation efforts. To facilitate rapid deployment, Infotehna’s technical team stands ready to deliver tactical project management services, training, and migration services for a turnkey approach. Stop wasting time and money on “solutions” that require expensive customization and integration. Infotehna’s all-in-one SubmissionExpert™ is designed to accelerate your return on investment and implementation. If your objective is compliance and you seek a costeffective solution for quality, R&D, regulatory, and marketing, look no further than Infotehna’s SubmissionExpert™.