SERVICES

Quality Assurance

Quality Assurance

LSK Global PS performs independent audits and internal quality management in compliance with the ICH-GCP. LSK Global PS provides audits based on the ICH-GCP and consulting service built on the experiences in the audits of a lot of domestic/foreign pharmaceutical companies and CROs, and the inspections by the regulatory authorities. In addition, LSK Global PS is providing services for the development of standard operating procedures(SOPs) complying with the ICH-GCP and domestic laws/regulations, consultation, and vendor assessment. LSK auditors are composed of the experts qualified as the RQAP-GCP(Registered Quality Assurance Professionals in Good Clinical Practice)

Brochure_Quality Assurance

Audit Process

Planning
  1. 01 Audit planning
  2. 02 Sending the audit introductory letter to auditees
Conducting
  1. 01 Document review
  2. 02 Interviews
  3. 03 Confirmation and evaluation of audit observations
Reporting
  1. 01 Issuing the audit report and audit certificate
Follow-up
  1. 01 Follow-up the corrective and preventive actions

Service Scope

Audit (Study specific, System)

Vendor / Sub-contractor assessment

SOP development and management

Audit CAPA management

Experience

Study Types

03_12_01 5045 40 35 30 25 20 15 10 5 0 Phase I Phase II Phase III Phase IV Medic al D e vi c e Bridging Study Others

Therapeutic Area

03_12_02 Onc ology Cardiovascular Neurology Endocrinology Medic al Genetics Va c cine Rheumat ology Orthopedics Inf ectious Disease Gastroent erology Others Hepat ology Ophthalmology Respir a t o r y 127 Projects As o f 2023.12.31
*The following cases are based on audit and inspection contract execution completion.