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Scientific Area

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

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

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