New Registration
Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
New drug registration detailsProduct registration is not always a one-time activity. Maintaining market authorization may require periodic renewals, updates to approved documentation, and regulatory submissions reflecting changes to the registered product.
URAS PV provides ongoing regulatory support to help clients maintain their existing product registrations throughout their lifecycle.
By coordinating these activities with our local regulatory partners, we help clients maintain regulatory compliance and reduce the administrative burden of managing registrations across multiple markets.
Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
New drug registration detailsMarketing authorization held by the manufacturer, an eligible local entity, a local distributor or another authorized applicant.
Registration models and MAH optionsPreparation and submission of regulatory variations and amendments reflecting changes to the registered product.
Drug variation detailsPrice registration, price declarations and reference pricing documentation where pricing approval is required before launch.
Price registration detailsTrademark availability searches, filing and maintenance through local intellectual property specialists.
Trademark registration detailsMAH arrangements, price registration, trademark protection, and an overview of our full registration support.
All registration servicesTell us about your products and target countries, and our regulatory team will outline the registration pathway.
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