Cratia Ltd. is a group of companies providing professional regulatory services for registration (marketing authorization), safety and quality management of medical products in 12 countries of the former Soviet Union: in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine.
The focus is on human health: medicines, medical devices, special food products, disinfectants and cosmetics.
We also provide a wide range of ancillary services in regulatory affairs: the establishment and maintenance of a pharmacovigilance system, the development and implementation of quality management systems (GMP, GDP, ISO 13485, HACCP/ISO 22000), medical and technical writing etc.
Our team includes more than 130 experts. All local activities (submissions, communications with competent authorities etc.) are performed by our local employees with high professional skills and experience, knowledge of national legislation and language. All activities are coordinated by our Head office in Ukraine, whose specialists communicate with the Customer, verify and prepare documentation, control the quality and timing of all operations.
Our work greatly facilitates the access of patients and healthcare professionals to the most advanced and high-quality medicines, medical devices and technologies.
The company’s portfolio includes:
- more than 150 manufacturers of medicinal products and active substances,
- more than 800 manufacturers of medical devices and equipment,
- more than 300 manufacturers of special food products and cosmetics.
Cratia Ltd. is not involved in distribution or marketing, is not associated with government officials, politicians and parties. We do not allow conflicts of interest, we value any partner equally, follow the code of business conduct and strictly respect confidentiality. We fully comply with local and international legal requirements representing manufacturers in the competent authorities.
Cratia Ltd. was founded in Ukraine in 2006 by a group of regulatory experts.
Since 2009 is a member of the European Business Association.
Since 2012 is a member of the Association of Medical Device Market Operators.
Since 2013 is a member of the American Chamber of Commerce in Ukraine.
In 2015 positive decision was received on the results of the PSCI (Pharmaceutical Supply Chain Initiative) audit.
In 2016 the quality management system was certified by Bureau Veritas for compliance with ISO 9001:2015.
Today Cratia Ltd. is a recognized expert in regulatory issues. We are invited as speakers to WHO events, we participate in working groups of the competent authorities and Associations, publish articles in national and international specialized media.