Our Values

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.

Pharegis team

Our team amalgamates unique combination of different experiences, ways of thinking and life missions under one simple vision: to help healthcare products manufacturers, talking their language and providing Clear Regulaory Answers.

Management

have many years of managing experience in international western companies in the first place. Our management experience in top 20 international manufacturers as well as top 10 CROs let us present you sophisticated, client-optimized and reliable service in Regulatory Affairs and Clinical trials fields for Russia, EAEU and CIS countries. Here is structure of our management board:

Experts and consultants

succesfully completed dozens of registration or clinical study projects. All of them had extensive working experience in internationational manufacturers and CROs before joining our team.

And some of our experts have long-track experience in health authorities of Russian Federation, federal expertise and state control institutions.

Together our experts, consultants and managers present well-balanced action team, always getting top quality results, which is one of the most important Value for Pharegis.

Joining us

If you feel that your values resonate with our ones and you have strong experience in the fields of our business, we would be happy to welcome you in our team.

If you want to open new opportunities in your career please send us your CV to careers@re.gth.gd.gth.rug.com

Drug Registration and Regulatory CRO Services in Russia: Our Advantages

Our key advantages we would like to share with our clients are the following:

1. Understanding Your business

Our management have in total more than 50 years of experience working in top 20 international pharmaceutical companies, we know pharmaceutical business processes in detail as well as all challenges that exist on Russian pharmaceutical market.

Our plans and deadlines are driven from the experience, current market state and regulatory conditions -  they are simply responsible. Nevertheless our solutions are oriented and focused on your business first, not processes and regulations.

Our in-project requests are reasonable, clear and formulated with understandable language. We do not practice micromanagement "guerilla tactics" like time- and responsibility-wasting "service" as “micro step - client's approval - micro step - client's approval etc”. Instead, we practice complex solutions for our clients' projects, fully transparent autonomy as well as advising optimal decisions to our clients.

2. Not just drug registration service but complete regulatory consultancy solution

In such complex, cross-functional and important role in healthcare industry that regulatory affairs play, we must and do focus on our clients business needs. They involve logistics, optimal choice of packaging, medical writing and medical support for marketing campaigns. This is regulatory-driven consultancy, not just simple regulatory service outsourcing.

3. Focusing on Quality

Quality of service is our strategic priority. Russian regulatory projects require uncompromising quality at all stages: from initial dossier analysis, translations review to preparation of clinical study report, planning of regulatory timeline and allocation of resources according to different forecasted scenarios.

All of us at Pharegis clearly understands that in any regulatory stage the price of a mistake can be dramatically high, whereas lack of quality can have remote consequences.

4. Flexibility, Simplification, Speed

This is not just a simple advantage, this is one of our essential values.

Flexibility gives us more options to deliver optimal cost-efficient solutions to our clients in every case, using wide project design options and volume of the services.

Simplification is the key to communication and the tool to minimize risk of misunderstanding - our clients do not need to know details of regulatory processes to manage and control them.

Speed means that we always can remove intermediate discussions, get to the point and deliver optimal decisions fast.

Those "3 in 1" values work best together, making cumulative effect.

5. Try it now

If a customer shows an interest in our services, our policy is to deliver our initial consultation and provide regulatory feasibility analysis for any project for free. You can contact us to get detailed and Clear Regulatory Answers.

Regulatory Affairs Services in Russia and Eurasian Union: Five Arguments for Pharegis

If you are planning to enter Russian or EAEU market with a new pharmaceutical product, sophisticated medical device or just want to start selling your active pharmaceutical ingredients to Russian partners, maybe you already realized that finding time-efficient, fully predictable and transparent service provider, focused and dedicated to such projects in its experience would be optimal choice for your business with long-term impact and perspective. Here are main reasons for how any service solutions provided by us can be beneficial to your business in Russia and EAEU.

1. Focused experience

We have over 15 years of extensive experience working 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 every other expertise authority responsible for registration of pharmaceuticals and medical devices in Russia.

2. Client-oriented flexibility

We are dedicated to providing outstanding services to our Customers. Any question that really concerns our  client can be discussed at top level with zero bureaucracy. We are trying our best to be flexible and compliant to client needs at first, not processes or our SOPs, yet sophisticated, specific and client-optimized.

3. Comprehensive expert approach

All our collaborators and experts are trained in international standards of business and international industry standards. 100% of our experts have higher medical or pharmaceutical education. Part of our staff have scientific degrees.

4. High ethical standards

Our ethics principles fully correspond to high industry standards established in top international companies. We are adherent to anticorruption legislation and measures. You can fully trust us on highly turbulent and Russian regulatory sphere.

5. Validity, predictability and quality of every process

We guarantee quality at every stage of our work. Our rule is: if quality of service at any step is not 100% satisfying, a customer can get that step readjusted for free.