Our company provides pharmaceutical products registration services and clinical trial management. We’ve been operating since 2000 and offer comprehensive pharmaceutical products registration services, from developing clinical trial protocols and obtaining clinical trial approval to registration and acting as the manufacturer’s authorized representative, as well as individual services:
- Determination of the optimal strategy for pharmaceutical products registration (the need and type of clinical trials, their design, the need and type of additional trials, determination of the registration budget);
- Development of a clinical trial protocol;
- Development of a package of documents required to obtain permission for a clinical trial, obtaining permission;
- Organization and monitoring of clinical trials;
- Conducting statistical analysis of clinical trial data;
- Writing a clinical trial report;
- Writing literature reviews of clinical and preclinical studies;
- A comprehensive service for compiling a dossier for registration of a pharmaceutical products in accordance with the rules of the EAEU and bringing the dossier into compliance with the requirements of the EAEU (in accordance with EEC Decisions 78, 79);
- Development of individual dossier modules for registration of pharmaceutical products in accordance with the rules of the EAEU and bringing the dossier into compliance with the requirements of the EAEU (in accordance with EEC Decisions 78, 79);
- Submission of registration dossiers and responses to regulator inquiries.
We look forward to collaborating with you and are always open to dialogue. We are ready to answer your questions and provide advice on any matters of interest.
