Electronic Common Technical Document (eCTD)

In November, 2000, the Fifth International Conference on Harmonisation (ICH5) was held in San Diego, California . At that conference, ICH (www.ich.org) announced an agreement on a harmonized structure and format for new product marketing applications - the Common Technical Document or CTD. That announcement introduced yet another challenge for pharmaceutical and biotechnology companies that are already being charged with compressing the time required to gain regulatory approval, i.e., to keep regulatory operations running smoothly while simultaneously re-designing processes and procedures to support the development of the CTD. Three years later at ICH6 in Osaka, Japan, the practical implementation of the CTD was still a major area of discussion, and for many companies continues to be an area of concern.

Pharmaceutical and biotechnology companies have taken different approaches to implementing the CTD within their organizations. Some companies have decided to outsource the process to a service provider while others have elected to implement new or updated electronic document management and publishing solutions to effectively create and manage the CTD and its electronic counterpart the eCTD. In either case, implementation of the CTD introduces additional regulatory compliance obligations with implications that reach beyond the ICH CTD/eCTD guidance itself.

How Patni Can Help
Whether your company is embarking on an internal CTD initiative or has elected to outsource the process, Patni's regulatory compliance experts can help. Patni's risk-based approach to the implementation and validation of computer systems used to support the creation and management of regulatory submissions allows our clients to focus their efforts on those areas and activities where the greatest value will be realized.

Our auditing and assessment services ensure that prospective technology vendors and professional services providers are operating in a manner that does not expose our clients to any unnecessary regulatory compliance risk. Patni's compliance and quality management services help our clients harmonize global processes and develop standard operating procedures to support collaborative submissions.

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