Regulatory

VIO Chemicals together with our partner Explicat Pharma offers full-service preparation of regulatory documents to prepare for marketability, including:

  • Drug Master Files (DMF)
  • CEP (Certificates of suitability to the monographs of the European Pharmacopeia)
  • Technical project management for the quality part of the Common Technical Document (CTD)
  • Preparation of the Quality Module of CTD
  • IMPD (Investigational Medicinal Product Dossier), IND (Investigational New Drug) applications
  • Chemistry Manufacturing Controls (CMC) Management: API-Analytics-Stability-Formulation

In addition to, and complementing the CMC section, the experts at Explicat Pharma offer a full range of preclinical / clinical regulatory and marketing documentation and services.