Marketing Authorisation (MA)
New Drug Authorisation (NDA)
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The Marketing Authorisation (MA) or New Drug Authorisation (NDA) is the ultimate goal. Though putting thousands of pieces of data into the right order, with the right summaries and overviews, then putting them in the required eCTD format and finally onto a CD-ROM is a daunting task; especially if everything seems to have changed since you last compiled an application. With an organised approach, all this can be broken down into smaller, more manageable activities, and Akos can help you with any or all of them, for example:
- Dossier review and gap analysis
- Preparation of Written Summaries and Overviews per ICH/CTD
- Adaptation of Common Technical Document formats (MAA/NDA)
- Preparation of Risk Management Plans as part of submissions
- Post approval activities
- Provision of ongoing regulatory affairs support
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk