I am happy to provide you with flexible GCP professional services in response to your requests to meet your needs.

Iwill conduct factual and objective GCP audits. I will enjoyyour company, be professional, be present and make yourday.

Specialties

  1. GCP audits including investigator site audits, vendor audits, systems audits
  2. CSV audits of computerized systems of DM / STAT vendors and clinical labs
  3. EMA and PMDA GCP Inspection Readiness
  4. GPSP and GVP vendor audits
  5. Process improvement
  6. SOP Management and Training Management

The examples of Professional Services

  1. Taking a position of a pharmaceutical company
    A)Head of Clinical QA, YL Biologics Ltd. (Jan.2018-Dec. 2019)
  2. Investigator Site Audits
    A) Japan since 2000
    B) USA in 2000, 2001 and 2002
    C) New Zealand in 2002
    D) Vietnam in 2013
    E) Korea in 2011, 2012 and 2013
    F) China in 2013
  3. Vendor / Supplier / Development Partner Audit
    A) Japan since 2000
    B) Phase Site in USA
    C) Phase 1 Site and three Clinical Lab Vendors in Singapore
    D) Vietnam in 2013
    E) CROs and Phase 1 Sites in Korea in 2011, 2012 and 2013
    F) China in 2013
    G) Development Partner Audit in 2023
    H) Remote vendor audits since 2020
  4. Mock Japanese PMDA GCP Inspections
    A) Sponsor Site and Two Investigator Sites in USA in 2003
    B) Investigator Site in China in 2014
    C) Sponsor Site and Two Investigator Sites in Japan in 2018
    D) Two Sponsor Sites in USA in 2019
    E) Sponsor Site in Korea in 2023
  5. Japanese PMDA GCP Inspection Readiness
    A) Full Inspection Readiness and Management in 2003 and 2004
    B) Full Inspection Readiness and Management in Japan in 20018
    C) Full Inspection Readiness at Sponsor Site in Japan in 2020
  6. EMA Inspection Readiness and Management at Investigator Site in Japan in 2018
  7. FDA Inspection Readiness Support in Japan in 2023