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

  • 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

  • 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

Our Clients