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

Our consultants with rich experience and expertise help you deal with various requirements from the PMDA, FDA, EMA and Asian authorities. Our services include strategy planning, dossier preparation and submission, and communication and negotiation with the authorities. We also support various types of study projects to be done at local medical institutions.

Project Examples

  • Document preparation support for written inquiries to be submitted to authorities in advance
  • Support for (basic) clinical testing at overseas medical institutions
  • Seeking doctor’s opinions and advice

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