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
Over 100 professionals
Over 500 clients
9 years of experience
Leading innovation
100% client oriented
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