GCP and GLP services

SeerPharma is pleased to announce its Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) services to the pharmaceutical, devices, and biotech industries.

SeerPharma has an in-depth knowledge of international requirements, and can guide you in ensuring your clinical trial will be acceptable by the relevant authority, including TGA, FDA, and EU.

SeerPharma's services include:

• Assistance and consulting in establishing an effective Quality Management System for clinical trials according to ICH guidelines
• Preparation of procedures (SOPs) required for GCP compliance
• Gap analyses and clinical trial audit preparation
  
• Clinical trials quality assurance services
  • GCP audits:
    1. Quality Systems audit
    2. Independent QA audits for Phase I-IV clinical trials including review of data
    3. Independent QA audits for bioequivalence studies
    4. Independent audits for bioanalytical laboratories
       
• Pre-clinical (non-clinical) GLP audits to 21 CFR Part 58 and OECD requirements
  
• Audits of computer systems used in GCP applications
  
• Training in:
  • GCP and drug development requirements
  • Pre-clinical (non-clinical GLP requirements)