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:

  • New Innovator Products
  • Generic Products
  • Hybrid Medicinal Products
  • Biologics
  • Biotechnology-Derived Products
  • Biosimilars
  • Combination Medicinal Prodcuts
  • Well-Established Use
  • Soviet Legacy Products
  • Orphan Medicinal Products
  • Immunological Medicinal Products
  • Plasma-Derived Medicinal Products
  • Herbal Medicinal Products
  • Breakthrough Therapy Designation
  • Advanced Therapy Medicinal Products
  • Biomedical Cell Products

Main focus on:

  • Generic / Hybrid Applications
  • Biologics / Monoclonal Antibodies
  • Biosimilars
  • Early Development of New Molecular Entities
  • Combination Medicinal Products
  • Bioequivalence
  • Regulatory Affairs