For more than 10 years we are assisting national and international companies on issues related to quality management systems of the manufacturer (GMP), import licensing and distribution (GDP) and pharmacovigilance (GVP).
We use the services of our own employees or involve external experts with relevant work experience and technical knowledge. We have deep knowledge of the national and international legislation, have extensive experience and are responsible for the result.
We are ready to perform the following works:
I. GMP inspections:
- In-depth analysis of SMF, preparation of recommendations;
- Independent on-site pre-audit;
- Staff training;
- Support during the inspection process by the competent authority;
- CAPA.
II. Site establishment:
- Consulting at the planning stage;
- Design, qualification of the project or it’s parts;
- Qualification of technological and laboratory equipment (IQ, OQ, PQ);
- Qualification of clean premises and engineering systems;
- Development of a Validation master plan;
- Development of Master Batch Records (MBR);
- Validation of the process;
- Development of SOP;
- Development of SMF;
- Staff training;
III. Import licensing and distribution (GDP)
- Independent audit of the importer, distributor;
- Consulting at the stage of warehouse planning;
- Development of SOP;
- Development of Master File;
- Staff training;
- Support during the inspection process by the competent authority;
- CAPA.
IV. Pharmacovigilance (GVP):
- Independent audit of the pharmacovigilance system of a representative office, service provider or manufacturer;
- Development of SOP;
- Development of PV Master File;
- Staff training.
Cratia provides professional services related to quality management systems in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.