New Registration
Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
New drug registration detailsExpanding into new markets requires more than identifying commercial opportunities. Navigating country-specific regulatory requirements, registration procedures, and local authority expectations is essential for successful market entry.
Whether you are planning to introduce pharmaceutical products, food supplements, or medical devices, obtaining the applicable regulatory approvals is a fundamental step toward placing your products on the market.
URAS PV provides comprehensive product state registration and regulatory affairs solutions across the CIS and Eurasian region. Through our established network of local regulatory teams, we support companies throughout the product registration lifecycle, from initial regulatory assessment and dossier preparation to approval, renewal, variations, and ongoing regulatory maintenance.
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.
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 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 detailsProduct registration support in the CIS, EAEU and Türkiye through our network of local regulatory teams.
National registration procedure: dossier preparation, local requirements and follow-up through approval.
National registration of medicines, including renewals and variations of existing registrations.
Registration under national and EAEU procedures, with dossier preparation and authority communication.
Registration under national and EAEU procedures, renewals and variations.
National registration procedure, renewals and variations of marketing authorizations.
Product registration applications to TİTCK, renewals and variations.
State registration of medicines, re-registration and variations.
State registration of medicines, re-registration and coordination of local requirements.
Instead of managing separate regulatory service providers in each country, clients benefit from centralized coordination through URAS PV and access to our network of local regulatory partners.
Regulatory requirements vary across the CIS region. Our local partners provide knowledge of national procedures, documentation expectations, and regulatory authority practices.
We recognize that market entry strategies differ. Our regulatory support is structured around the client's preferred commercial arrangements, authorization-holder strategy, and target markets.
From initial registration to variations, renewals, price registration, and trademark protection, URAS PV provides coordinated support across the different stages of a product's regulatory lifecycle.
Our centralized coordination model enables clients to streamline communication, monitor registration activities, and manage multiple country-specific processes through one service relationship.
Tell us about your products and target countries, and our regulatory team will outline the registration pathway.
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