Quality Commitment

Statement of Compliance with Good Laboratory Practice Regulations

Retroscreen Virology Ltd. carries out Pre-Clinical studies that comply with the following principles and regulations:

  • The United Kingdom Good Laboratory Practice Regulations 1999 Statutory Instrument No. 3106.
  • OECD Principles of Good Laboratory Practice, (Revised 1997).

Clinical Studies where Retroscreen Virology act as a Clinical Research Organisation or Sponsor are carried out in line with ICH – Good Clinical Practice and are in compliance with the following:

  • Statutory Instrument 2004:1031 The Medicines for Human Use (Clinical Trials) Regulations 2004
  • Statutory Instrument 2006:1928 The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
  • Statutory Instrument 2006:2984 The Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations 2006
  • EU Directive 2001/20/EC
  • EU Directive 2005/28/EC
  • The Rules Governing Medicinal Products in the European Union: Volume 10 Clinical Trials

Quality Assurance Statement

Retroscreen Virology Ltd. specialises in the development of antiviral compounds and vaccines that will prove useful in fighting viral disease worldwide. This involves working with numerous pharmaceutical companies to assist them with the identification and screening of compounds and vaccines.

In addition to having world renowned expertise in the fields of academic and research virology, Retroscreen Virology Ltd. has its own internal quality department that ensures this expertise is applied to studies in a way that both meets client needs and complies with regulatory requirements within a current Good Laboratory Practice / ICH -Good Clinical Practice environment.

The facilities at Retroscreen Virology Ltd. are periodically audited by external GLP experts. In addition, the facilities are audited by the UK GLP Monitoring Authority (UK GLP MA), which is governed by the Medicines and Healthcare products Regulatory Agency (MHRA). These audits are to ensure regulatory compliance is maintained.

Quality Assurance ensures that the methods, practices and procedures deployed during trials and studies reflect current practice and comply with statutory regulations.

The Quality Assurance group performs audits to ensure that true and accurate representations of data are reported during conduct of studies at Retroscreen Virology Ltd.

The QA programme aims to maintain current systems and drives for continual improvement of systems and operating procedures.

This programme aims to ensure that a client's expectations are consistently met and that studies provide high quality data to assist the client with their activities in a controlled and cost effective manner.