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Research Quality Association

phone +44 (0)1473 221411
web http://www.therqa.com/
email 3 Wherry Lane, Ipswich, IP4 1LG

Quality Systems Guide

This guide concentrates on the core, underlying principles of quality that are pivotal – explicitly or implicitly – to all quality management standards that impact on research and development.

These principles are also fundamental to the conduct of efficient, reliable and credible scientific and clinical work, and will help you to design and implement a practical Quality System; a Quality System that works for your organisation, to make it more productive and compliant, rather than making you work for it by producing unnecessary bureaucracy.
Quality Systems Guide
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News and Press Releases

Top 20 Specialty Pharma Continues to Rely on Calyx EDC for Multiple Early Phase Studies

Nottingham, England and Morrisville, NC – February 14, 2022 - Calyx, the eClinical and Regulatory solutions and service provider relied on for solving complex data challenges in clinical research, announced today that a Top 20 specialty pharmaceutical company will continue to rely on Calyx’s electronic data capture (EDC) system for a series of upcoming, early phase studies.
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White Papers

R&D to Product: How to Reduce Costly Scale-Up Problems

Natoli Engineering Company, Inc.

When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scaleup and performance of the formulation at production levels. Problems with capping/lamination and sticking/ picking are often first realized when a formulation is introduced to a level of compression required to supply market demand.
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