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

• Registration of Drug Products in Russia
• Registration of Active Pharmaceutical Ingredients (API) in Russia
• Drug Registration in Eurasian Economic Union (EAEU) and CIS countries
• Registration of dossier variations

3. Clinical Studies Management in Russia

• Clinical Studies Required for Drug Registration (BE, TE, local Phase III)
• Phase I, Phase III Clinical Studies Management
• International Phase III Clinical Studies
• Postmarketing Clinical Studies Management
• Clinical Studies for Medical Devices

4. Preclinical Studies Management

• Preclinical Studies for Drug Registration
• Preclinical Studies for Registration of Biosimilars and Immunobiological Productsal Studies for Biopharmaceuticals
• In Vitro Preclinical Studies in Russia

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:

• Registration Feasibility Assessment;
• Assessment of Registration Budget and Timeline;
• Calculation of Clinical Study Budget and Timeline;
• Calculation of Preclinical Study Budget and Timeline.

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