Regulatory

We are pleased to offer the following services in the field of registration:

1. Registration of drugs

• Preparation of dossier
• Composition of dossier
• Testing of methods of analysis included in the dossier
• The final formation of the dossier and submission to the Ministry of Health
• Biomedical writing
• Selection of clinical centers
• Insurance
• Support of all necessary regulatory procedures for clinical trials
• Purchase of consumables
• Monitoring the progress of the clinical trials
• Development and maintenance of clinical trials database
• Preparation of the clinical trials report

2. Registration of dietary supplements

3. Registration of medical devices

• Examination of the manufacturer's documents set for compliance with state registration requirements
• Preparation of applications to the Federal Service on Surveillance in Healthcare
• Contracts with test databases
• Organization of technical and toxicological tests
• Preparation of the registration dossier and submission of documents for registration
• Organization of clinical trials
  

Examples of completed projects:

• Registration of  generics with carrying out therapeutic efficacy
• Registration of generics with carrying out bioequivalence
• Registration of medical devices