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Our news

  • 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
  • 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
  • 03/04/2019:  Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.

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E-mail:      info@pharegis.com

pharegis.com | regdrug.com

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Regulatory Events Russia

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Russian Regulatory News

 Top regulatory service Russian CRO Pharegis values

We adhere to our values, which are essential in our daily work:

1. Quality of services

This is our primary value. It concerns all parts of our projects - from your first phone call to us to most challenging regulatory timeline and target. It is going from quality of all aspects of internal processes in our team.

2. Reliability

Reliability in any circumstances and any legal or regulatory conditions. This is our top value that combines with quality of service. We are looking forward to be not only your best service provider but also your best and reliable friend on Russian and CIS markets overall.

3. Ethical approach to business and clarity of processes

corresponding to highest industry standards. Ethics of business is a long term investment of essential importance and we at Pharegis adhere to this principle. Our Ethics in fact is a part of our Quality and Reliability core Values we are proud of.

4. Flexibility, Simplification, Speed 

or just "FSS" is one of our key advantages on the market. Flexibility gives us more options to give you Clear Regulatory Answers anywhere and anytime. Simplification is the key to understanding since you do not need to understand regulatory process to manage and control it with us. Speed means we always can remove intermediate discussions, get to the point and give you right decisions fast. And you know, those 3 in 1 values work together and make cumulative effect - so you can see them combined!

5. Forecast, Result, Responsibility. 

When we say "result", first of all we assume the agreed terms and outcomes of any project we take. Those key project properties are our main KPIs. In particular that means our regular review and optimization of project's strategy, as well as using different tactics to complete a project on time. We take our responsibility seriously 

 Pharegis values keyboard

 

 

 

 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

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

3. Clinical Studies Management in Russia

4. Preclinical Studies Management

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.

Pharegis team and career possibilities: registering drugs in Russia, register biosimilars, register generic drugs, conduct clinical studies, bioequivalence studies, pharma regulatory service in Russia by CRO Pharegis expert team

Pharegis team

amalgamates unique combination of different experiences, ways of thinking and life missions under one simple vision: to help business, talking on its language and giving 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, Ukraine and CIS countries. Here is structure of our management board:

Pharegis organigram

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: This email address is being protected from spambots. You need JavaScript enabled to view it.

Advantages of drug registration, generics registration, biosimilar approval, CRO services and pharma regulatory service in Russia provided by CRO Pharegis

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

If you are planning to enter Russian or EEU 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 EEU.

Choose CRO for drug registration and approval in Russia, fast biosimilar and generics registration, managing local clinical studies, bioequivalence and therapeutic equivalence, preclinical studies, drug regulatory service in Russia - consider Pharegis

1. Focused experience

We have over 15 years of extensive experience working with Russian Healthcare system namely Ministry of Health, Roszdravnadzor, State Center of Expertise and Control of Remedies for Medical Use and every other expertise authority responsible for registration of pharmaceuticals and medical devices in Russia.

2. Client-oriented flexibility

We provide outstanding service to our clients 24/7. 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, client can get that step readjusted for free.

Pharegis why choose us apple

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