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We establish reliable access for medical products to emerging markets

We are experts in regulatory, safety and quality affairs for medicinal products and API’s, medical devices, special food products and cosmetics. Our focus are emerging markets with developing and rapidly changing legislation.

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Our work facilitates patient access in 12 countries to modern and quality medicines

For more than 14 years we have been assisting leading international pharmaceutical manufacturers to establish registrations in post-Soviet countries, with a total population of over 250 million people.

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Competent service for modern technologies: efficient solutions for medical devices

By understanding the requirements of EU MDR and MDD, we quickly, efficiently and competently assist medical devices manufacturers to achieve registration and compliance with all national requirements in 12 countries.

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Establishment and maintenance of a pharmacovigilance system, drug safety management

We establish and maintain systems of monitoring of adverse events at the national level, achieving compliance with local requirements, managing safety in time, collecting data for assessment of the risk/benefit ratio, improving patient safety.

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Years of experience and presence in 12 countries of the CIS and the EAEU

Eurasian Economic Union

Quality

Top quality without compromises. The quality management system covers all areas of activity, is certified according to ISO 9001:2015 and is audited annually by international body and our clients.

Quality >>

Trust

Since 2006, we have been trusted by the most complex projects and we have met expectations. Today we cooperate with more than 1000 international manufacturers of healthcare products.

Portfolio and references >>

Team

Our team consists of over 130 professionals with excellent knowledge of national and international legislation. We love our work and always try to do more than is expected.

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Code

Our work is related to health and life. We are aware of our responsibility, strictly following national and international legislation, confidentiality and business ethics principles.

Code of Conduct >>

We are professionals in products for human health. Our services:

Registration of medicines: feasibility studies, filling the registration dossier and Application, national labeling and IFU, submissions and follow-up, regulatory intelligence.

Pharmacovigilance: establishment and maintenance of the local system, designation of LCP, routine activities, literature monitoring. Medical and safety writing: RMP, ACO, PSUR.

Registration of medical devices: filling the Application and registration dossier, translations, national labeling and IFU, testing, submissions and follow-up. Authorized representative.

Development and implementation of quality management systems: GMP, GDP, GVP, ISO 13485, HACCP / ISO 22000. Independent audit of the supplier.

Registration of medical devices: filling the Application and registration dossier, translations, national labeling and IFU, testing, submissions and follow-up. Authorized representative.

Medical, safety and technical writing for medicines, medical devices, special food products and cosmetics.

+44 20 8123 9125

info@cratia.com

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