Product development and regulatory/legal compliance

Animal health product approval applications and development compliance

  • Support for applying for approval to manufacture and sell veterinary drugs and other products
  • Support for specifying feed additives
  • Investigation of overseas approval dossiers
  • Gap analysis and advice
  • Management of progress in the trial process (domestic GCP clinical trials, GLP target animal stability testings, GLP residue testing, etc.) and preparation of associated reports
  • Creation of manufacturing and sales approval (as Market Authorization Holder applications) and associated advice

Good Post-marketing Study Practice (GPSP)

  • Research into efficacy and safety during the new product reassessment period (6 years) and collection of associated data
  • Research into efficacy and safety during the efficacy addition and target animal addition reassessment period (2 years) and collection of associated data
  • Planning and implementation of research into the utilization track record for new drugs and other products and creation of reports and research summaries

Safety Data Sheet (SDS) creation and associated support

  • Creation of SDS
  • SDS creation support system

Import agent services for in-vitro diagnostics and other products

  • Agency services for ordering and import procedures for veterinary drugs and medical devices that are not yet approved or sold in Japan (which require import confirmation)
PAGE TOP