Regulatory Service and Contract Research: Our Areas of Expertise

Local CRO and Drug Regulatory Service Expertise

We have over 15 years of extensive experience with Russian Healthcare system namely Ministry of Health, Roszdravnadzor, State Center of Expertise and Control of Remedies for Medical Use and others. And we combine best planning and tactics to get your project done fast and without issues. Our way of communication with health authorities is based on high ethical standards. 100% of our experts and mamgers 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. State Registration of Pharmaceuticals. Drug Renewals and Variations

• Registration of Medical Drugs in Russia
• Registration of Active Pharmaceutical Ingredients (API) in Russia
• Drug registration in CIS countries, Ukraine and Georgia
• Registration of dossier variations

3. Clinical Studies Management in Russia

• Registration Clinical Studies Management
• 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

• Registration Preclinical Studies
• Registration Preclinical Studies for Biopharmaceuticals
• In Vitro Preclinical Studies in Russia

5. Certification and Declaration of Quality for Medical Drugs in Russia, EEU and Ukraine

6. Registration and Quality Certification of Medical Devices in Russiam EEU and Ukraine

7. Pharmacovigilance and Materiovigilance Management in Russia, EEU and Ukraine

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.

You can send details of your question to This email address is being protected from spambots. You need JavaScript enabled to view it. to get fast and free:

• 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.