Drug registration and regulatory strategy

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.

Experts in drug regulatory strategy