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 unapproved 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)
