Guides and Ebooks

CMC writing:
Six tips for delivering top-class dossiers.

Practical pointers to navigating authority guidance and
getting the balance of technical eCTD content right first time.

From the conception of a pharmaceutical product, data is captured about its chemistry, about its manufacturing and about any relevant controls.

When it comes to applying for marketing authorization, much of this information will form the basis for the CMC sections of the eCTD dossier (Module 3: how a product was made and tested) for submission to various licensing authorities.

To help Regulatory teams navigate the requirements and find the sweet spot for CMC filing, Senior Regulatory Affairs Manager, Cecilia Rodica Avram, and Regulatory Affairs Manager, Andreia Montes Da Silva, have put together this useful guide which highlights some key considerations and practical tips to creating dossiers that are right first time.

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