Analyze Business with Scientific Eyes Business Science & Technology Co., Ltd

We provide support for various regulatory challenges in dealing with current and future legislation and regulations. We offer a wide range of global services that are tailored to your needs, including research, consultation, application support and agent services.

Project Examples

  • Trend analysis of domestic and foreign regulations related to healthcare, chemical, agrochemical, food industry
  • Legal and regulatory interpretation and strategy proposal
  • Dossier preparation and submission support
  • Local agent (incl. local partners)
  • Research and gathering of technical data (e.g. toxicity data) necessary /required for an application
  • Data gap analysis: analyzing existing data to find out what’s missing for filing an application
  • Preparation of risk assessment reports
  • Preparation of SDS
  • Document review (application form, instructions, attached documents, SOP, etc.)
  • Communication, discussion, meeting with local authorities
  • Seeking expert advice and evaluation
  • Mock inspection services
  • Local Lab study management

Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems-WC500135113

『製造/GMP適合問題によって生じる医薬品の供給不足に関するリフレクションペーパー (EMA)』(ご参考用翻訳版)

Interface between REACH and Cosmetics regulations-ECHA-14-FS-04-EN