Rika Saito

Regulatory Affairs Practice – Japan

BACKGROUND

FOCUS AREAS

More than 30 years of experience in non-clinical development and is an expert in nonclinical pharmacokinetics and bioanalysis.

  • Non-Clinical Pharmacokinetics
  • Bioanalysis

As an expert in non-clinical pharmacokinetics, Rika Saito builds Japan’s development strategy regarding non-clinical studies to support PMDA consultation and J-NDA. She has extensive experience creating CTDs and responding to PMDA queries in non-clinical parts.

She has more than 30 years of experience in non-clinical development and is an expert in nonclinical pharmacokinetics and bioanalysis.

She builds Japan’s development strategy regarding nonclinical studies to support PMDA consultations and J-NDA. She has extensive experience creating dossiers for PMDA consultation, responses to PMDA queries, and CTDs in non-clinical parts. She can establish and maintain business relationships with clients, vendors, etc. She has also actively engaged in strategic customer development activities to support business development in recent years.