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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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Regulatory Events Russia

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Russian Regulatory News

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.


News and press releases

  • EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
  • Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
  • EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna, CHMP, 15/09/2023