Service Types

Publishing and Submissions Management

• eCTD, non-eCTD electronic and paper submissions
• Standalone publishing or as part of integrated regulatory affairs project management

High quality, professionally published submissions are now an expectation of all regulatory authorities and use of the eCTD is increasingly demanded. At Wainwright Associates, we are committed to ensuring that the published output bears the high quality and user-friendly finish that will create the right impression and facilitate review throughout validation, assessment and approval.

Using our state-of-the-art publishing technology, we publish and manage submissions across the full spectrum from paper, non-eCTD electronic submissions, to eCTD and ensure that your submission is compliant with the individual requirements of the receiving regulatory authorities.

All kinds of regulatory submission are handled, including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and post-authorisation procedures (e.g. Follow-up Measures, Variation Applications and Renewals).

Our service is flexible and geared to the needs of the individual client. Publishing and submissions management is available as a service in its own right and we will be pleased to handle all types and complexity of submission in any of the above formats. Alternatively, it is available as part of the comprehensive package of regulatory support for a particular project. Incorporation into the regulatory project plan ensures an efficient transition from preparation of the submission components to dossier construction, and means that deadlines are achieved.