At Azierta we support:
- Establishing the regulatory strategy for the presentation of a registration dossier for a drug, studying in depth the objectives of the product and the client, and selecting the most suitable registration procedure for each company.
- Preparation, presentation and follow-up of the registration dossier until the marketing authorisation of a medicine is obtained.
- Regulatory support in all local activities necessary for the marketing or maintenance of the medicines.
- We adapt the required common eCTD format by requesting the necessary information.
- Review of promotional materials for medicines, selecting the appropriate texts to achieve the marketing objectives.