Advisory-expertise on GxP (GMP, GLP, GCP, GDP, etc.).
Development and preparation of documentation for the manufacture site quality system
Certification Advisory and expert services
Registration Advisory and expert services
2. Medical documentation
Development of any necessary medical documentation is carried out by professionals specializing in medical scientific expertise. They will prepare all the necessary documents with the compliance EMEA, FDA, ICH GCP, Ministry of Health Russia and Federal state budgetary institution "Center of expertise and control".
Our staff is ready to develop for you:
Information for patients;
Documents of standard operating procedures;
Patient consent form for the study;
3. Translation and statistical analysis
Among other things, our company is ready to conduct a statistical analysis of the research results. Such services include:
Advice on medical statistics, development and implementation of research analysis;
Providing all types of clinical study reports: medical, integrated and statistical.
If necessary, all medical and pharmaceutical documentation can be made in other languages. This is often necessary at registering drug or conducting clinical trial, when the manufacturer of the drug or any of its components is foreign company. For this purpose we use the services of professional translators.
4. Formation of the registration dossier
Upon request, our specialists are ready:
Prepare, check and execute the main documents - normative documentation (ND), as well as instructions for medical use;
Provide a list of documents that will be needed when compiling the registration dossier;
Make layout design documentation, primary and secondary packaging;
Check the finished documentation;
Properly send the ready-made files to the Ministry of Health and Social Development of the Russian Federation.
5. Staff training
Training (knowledge center ImGP) - trainings for personnel on the following topics:
"Basic sales skills"
"Interview: Steps: Assessment of competencies -" STAR "
Commercial proposal for IMGP training