We prepare and implement training programs for continued education of applicant’s / manufacturer’s / CRO’s / clinical site’s / test site’s staff in the following areas:
Applied Scientific Aspects
Early Development
Pharmaceutical Development
Non-clinical Development and
Clinical Development
of Medicinal Products Belonging to Different Classes
Procedural aspects of granting a marketing authorization and related procedures, including:
Variations to Marketing Authorization Applications
Renewal of Marketing Authorization Applications
Bringing a Marketing Authorization Application Dossier into Compliance with EAEU Requirements
Clinical Trial Applications
We counsel on the following classes of products:
  1. New Innovator Products
  2. Generic Products
  3. Hybrid Medicinal Products
  4. Biologics
  5. Biotechnology-Derived Products
  6. Biosimilars
  7. Combination Medicinal Prodcuts
  8. Well-Established Use
  9. Soviet Legacy Products»
  10. Orphan Medicinal Products
  11. Immunological Medicinal Products
  12. Plasma-Derived Medicinal Products
  13. Herbal Medicinal Products
  14. Breakthrough Therapy Designation
  15. Advanced Therapy Medicinal Products
  16. Biomedical Cell Products
Main focus on:
  1. Generic / Hybrid Applications
  2. Biologics / Monoclonal Antibodies
  3. Biosimilars
  4. Early Development of New Molecular Entities
  5. Combination Medicinal Products
  6. Bioequivalence
  7. Regulatory Affairs
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