POST-AUTHORISATION

Whether or not we assisted in the development and submission, we are able to provide standalone or ongoing services for post-approval maintenance. This can range from long-term support of all variations, renewals, PV and eCTD versioning through to a standalone submission of a change request to an Agency. We understand that this activity is a cost-burden to industry, yet is necessary as part of ongoing compliance. We are able to provide services in Life-cycle management that could minimise costs and meet critical timelines in order to ensure MAs are kept up-to-date.

Some of the services offered in this area are:

• Variations, renewals, PSUR and eCTD lifecycle maintenance
• Large volume variations, grouping for EU and minimise administrative burden for global submissions
• Consolidation of renewals, preparation of dossier and submission
• Pharmacovigilance activities
• MA transfers and associated variations during acquisition transactions

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