Pharmaceutical Consultation

Pharmaceutical Consultation

Consulting on drug pharmaceutical application

  • Support for drug pharmaceutical application
  • Development of marketing authorization application form (including partial changes)
  • Development of marketing license application form (including application for renewal)
  • Development of manufacturing license application form (including application for renewal)
  • Development of distribution license application form (including application for renewal)
  • Development of application form for registration of the Drug Master File (including application for amendment)
  • Development of application form for accreditation of foreign manufacturer (including application for renewal)
  • Domestic administrator upon registration of Drug Master File
  • Substitute for application and other procedures for a foreign manufacturer

Support for tasks related to Good Manufacturing Practice (GMP), Good Quality Practice (GQP) and Good Vigilance Practice (GVP)

Consultation on other general issues related to pharmaceuticals