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SERVICES
OUR SERVICES
Regulatory Affairs
We provide an assessment on registration of goods with the National Medicine, Food and Medicine Technology Administration (ANMAT) and the National Seeds Institute (INASE).
Our advice also includes strategies for the registration of products, approval, and marketing authorization in Argentina, as well as recommendations on clinical trials.
We take care of:
- Providing advice on the current regulatory framework.
- Providing advice on the registration strategy for the approval of products and marketing permits in Argentina.
- Providing recommendations in terms of clinical analysis.
- Preparing and submitting product registration applications before Health and Administrative Authorities.
- The comprehensive management of the administrative procedure, until the authorization of the product is obtained.
- Compliance and renewal of records and maintenance of the marketing permit.
