For more than 10 years we perform medical, technical and safety writing for national and international manufacturers. We have deep knowledge in national and international legislation, extensive experience and are responsible for the result.
We use our own writers or select external experts with professional experience and scientific knowledge in the necessary areas of medicine. We can do the work based on your template or use national and international regulatory documents and guidelines. Any work performed by us undergoes thorough scientific and editorial verification, independent quality control.
We are experienced in writing of the following documents:
I. Parts of the registration dossier in CTD format:
- Module 1.8.2. Risk Management Plan;
- Module 2.3. Quality Overall Summary;
- Module 2.4. Non-clinical Overview;
- Module 2.5. Clinical Overview;
- Module 2.6. Non-clinical Summary;
- Module 2.7. Clinical Summary;
- Module 4. Non-clinical Data;
- Module 5. Clinical Data;
- Search and selection of literature data for the Modules 4 and 5.
- 1.8.2. Risk Management Plan;
- Addendum to Clinical Overview;
- Periodic Safety Update Report (PSUR);
- Periodic Benefit-risk Evaluation Report (PBRER);
- Pharmacovigilance System Master File, SOPs.
III. National works to be submitted in a specific country:
- Verification of the dossier for compliance with national requirements (feasibility study);
- Translation of necessary parts, development of national documents and drafting the registration dossier;
- Development of instructions for use (leaflet);
- Development of packaging labeling;
- Development of quality control methods (regulatory document);
- Adapting EU RMP or Core RMP to national requirements;
- Pharmacoeconomic and medical analysis and justification for inclusion in the list of essential medicinal products.
Cratia Ltd. performs expert work on the development of parts of the registration dossier 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 for work performance.