Pharegis is a senior regulatory consultancy focused on complex market-authorisation and lifecycle work.
Regulatory focus and operating model
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, a transparent and time-efficient service provider, focused and dedicated to such projects in its experience can be an effective choice for your business with long-term impact and perspective.The following are the main reasons why 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 the the Russian healthcare system namelyMinistry 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 first, while maintaining the required processes and 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 education in medicine or pharmacy. Some members of our staff hold scientific degrees.
4. High ethical standards
Our ethics principles fully correspond to high industry standards established in top international companies. We adhere 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 throughout 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.
Team and leadership
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 contact Pharegis