About The CQA Company

The CQA Company provides expert Quality Assurance advice to pharmaceutical, biotech and medical device companies globally. Our GxP audits, quality management system development services and inspection readiness assessments are performed by highly qualified, specialist, regularly trained staff members, in line with current best practices and quality guidelines. Our philosophy is one of teamwork, positivity, communication, responsibility and adding value. The CQA Company does not offer a theoretical approach to Quality Management and reviewing, instead all of our personnel have direct, hands-on experience in Clinical Quality Assurance and ICH GxP with the ability to provide a real-world insight into the role.


Our Services

List of services

GCP Audits

  • Clinical Studies Phases I to IV
  • Central Laboratories
  • Clinical Laboratories
  • Advance Products & Medical Devices
  • Biotech environment
  • Pharmacy

GMP Audits

  • Raw Materials supplier
  • Laboratory supplies (equipment/chemicals) & testing facilities
  • Printed packaging material supplier & production facilities
  • Product recall assessment
  • Personnel training & hygiene

GPvP Audits

  • PV/REMS Audits (EMA/FDA/MHRA) Sponsors & vendors
  • EU – Audits of Risk Management Plans
  • Clinical Site Audits
  • REMS System audits
  • PV inspection preparation/ hosting

GLP/GcLP Audits

  • Facilities
  • Laboratories (Equipment, Reagents & Materials)
  • Study Performance
  • Storage of records and reference material
  • Data Reporting (LIMS)

Vendor Audits

  • GCP, GMP, GLP, PV
  • Clinical Research Organisations
  • Phase I units
  • Central Laboratories/Specialised Laboratory Testing Facilities
  • Data Management
  • Translation Companies
  • IT and e-TMP

QMS Development

  • Strategic Development
  • QMS Assessment and legacy operations
  • GAP studies
  • SOP Development and preparation
  • Process Mapping
  • Risk Management
  • Staff Training
  • QP Services

Inspection Support

  • EMA, FDA and MHRA experience
  • Mock audits/inspections
  • Pre-inspection training
  • Mock inspection interviews
  • Evaluation of company’s inspection readiness
  • Inspection set-up
  • On site inspection support


Knowledge

The current Guideline for Good Clinical Practice (GCP), E6 (R2), was adopted by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2016 and came into effect in Europe in June 2017. The CQA Company has worked with many companies in order to incorporate the 25 Amendments in their Quality Management Systems. 

The Amendments update the guidance to include covering Risk Management, Sponsor Oversight and Advances in Clinical Trial technology. If you would like assistance with the implementation of the new amendment, then The CQA Company can supply the required Gap Analysis, Process mapping, risk management and QMS development services to assist your company to maintain the highest levels of GCP compliance.