Regulatory Affairs Global Support

Product description

We offer a service adapted to the needs of your company, working from the initial stage of registration to day-to-day regulatory activities, providing our experience in different areas, and thus offering global regulatory solutions and external support if required.
  • Regulatory Strategy
  • Regulatory Intelligence
  • 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.
For more information please visit https://www.azierta.com/en/pharma/regulatory-affairs

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Specifications

Categories Contract Services - Pre Clinical Trials, Clinical Trials Stages 1-4, CRO, Clinical Data; Pharmaceutical Packaging; Contract Services - Contract ServicesRegulatory Affairs
Sales markets Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America

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