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Accenture’s Regulatory Affairs and Regulatory Operations professionals have combined their expertise to develop this valuable solution that enables clients to quickly locate regulatory standards information.
Accenture’s Global eCTD Guidance Interpretation provides predefined organizational interpretation of over 42 electronic submission specifications. This solution represents hundreds of hours of cross-functional regulatory and process research, analysis and interpretation of current agency guidance and specifications compiled into one offering.
Our Global eCTD Guidance Interpretation offering enables clients to access US-based interpretation or combined EU and Canadian interpretation. Computer-based training supports the implementation of the guidance and customization options are available to assist specific organization requirements.
Accenture Accelerated R&D Services delivers digitally enabled technologies and services across the clinical, regulatory and pharmacovigilance functions around the globe. This business service allows pharmaceutical companies to bring drugs to market faster, at less cost and with reduced execution risks.
Accenture Accelerated R&D Services can help our clients:
We work with industry-leading Life Sciences companies in more than 50 countries, as well as more than 125 public health organizations. We have more than 20 years of global delivery experience.
Through a broad array of consulting services for regulatory affairs and operations, Accenture supports all aspects of global submission management. Our service offerings are joined with advanced technology to offer flexible solutions that address functional needs and augment in-house capabilities. Additional services include:
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