Services

Regulatory maintenance and scientific support

  • Registration of medicinal products
  • Registration of pharmaceutical substance
  • Registration of medical devices
  • Registration/certification of veterinary products
  • Registration/certification of food supplements
  • Registration/certification of specialized food, baby food, dietary food (for treatment and prevention)
  • Registration/certification of cosmetics, perfume and hygienic means
  • Registration/certification of mineral water, energy drinks
  • Consultation for dossier compilation
  • Preparation of artworks of primary and secondary package
  • Preparation of production master files
  • Development of medical documents
  • Medical translations
  • Pharmacovigilance/span>

Licensing

  • Licensing of manufacturers of medicinal products according to the requirements of the Ministry of Industry and the Customs Union
  • Manufacturing site audit
  • Receipt of GMP of the Union

Researches

  • Non-clinical studies
  • Clinical studies (phases I-III)
  • Bioequivalence studies
  • Postmarketing studies (phase IV)
  • Comparative test of dissolution kinetics (Biowaiver)