Flexible Registration Models
Marketing authorization held by the manufacturer, an eligible local entity, a local distributor or another authorized applicant.
Registration models and MAH optionsEntering a new market requires a clear understanding of the applicable registration pathway, documentation requirements, and regulatory procedures.
URAS PV supports the registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
Whether you are registering a single product in one country or managing a portfolio across several markets, URAS PV offers a coordinated and flexible approach tailored to your registration objectives.
Throughout the registration process, URAS PV ensures that clients remain informed through timely and regular updates, providing clear visibility into the current status of each application, completed milestones, pending requirements, and upcoming regulatory steps.
Marketing authorization held by the manufacturer, an eligible local entity, a local distributor or another authorized applicant.
Registration models and MAH optionsRenewal of existing marketing authorizations and registration certificates, with ongoing support to maintain your registrations throughout their lifecycle.
Drug license renewal detailsPreparation 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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