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Services and areas of expertise for drug registration, biosimilar registration, generic drugs registration, local clinical studies, bioequivalence studies, preclinical studies, pharma regulatory service in Russia provided by CRO Pharegis

Our Regulatory Affairs Services Expertise

We have over 15 years of extensive experience with Russian Healthcare system namely Ministry of Health, Federal Service for Surveillance in Healthcare (Roszdravnadzor), Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ (FSBI ‘SCEEMP’) and others. We combine best planning and tactics to get your project done swiftly and without issues. Our way of communication with health authorities is based on high ethical standards. 100% of our experts and managers have higher medical or pharmaceutical background. We are adherent to anticorruption legislation and measures. And we guarantee you quality at every stage of our work.

Shortly, we provide full scope of exceptional quality service for you in following areas:

1. Elaboration of Regulatory Strategy. Regulatory Analysis and Consulting.

2. Drug Products Registration, API registration, Registration Renewals, Drug Dossier Variations

3. Clinical Studies Management in Russia

4. Preclinical Studies Management

5. Certification of Drug Products in Russia and EAEU

6. Registration and Certification of Medical Devices in Russia and EAEU

7. Pharmacovigilance and Materiovigilance Services in Russia and EAEU

You can trust us to get either full registration solution from sophisticated expert analysis in frames of initial free registration feasibility assessment to first import of registered product that will include preclinical adjustment and registration clinical study, or you can order to focus on specific process that you need to be finished fast and with high quality, nevertheless of grade and stage of that particular process.

Send us corresponding request for:

We will be pleased to help your business needs and send you our Clear Regulatory Answers.