International ClinicalAuditing and Quality Management
With over 10 years of experience, IT’sQA is a global leader in quality consulting services focused exclusively in clinical research.
Our 30+ consultants in 19 different countries include physicians, scientists, former regulators, and industry professionals with an extraordinary depth of knowledge in all areas of quality assurance and compliance in GCP, GLP, GMP, pharmacovigilance, CAPA and risk management. The average experience of the consultants is 14 years.
IT’sQA offers a broad range of service capability to help biopharmaceutical and medical device companies in all areas of quality assurance from auditing to quality management services, process optimisation and integration.
NEWS: Please note we have a new telephone number
05 September 2012: IT’sQA announces the enhancement of their services to include the medical device sector (Class I, IIa & IIb devices). Experience include ISO 13485 and 21 CFR 820, Project Managing, generation and maintaining of Design History Files, European Technical Files and International Submission Files for Medical Devices; International Submission Requirements e.g. 510(k), Health Canada, Japan, Brazil, China etc. Regulatory and Design Assurance Support – RA/QA Representative on new product development; Product testing, product investigation, multi-site development teams (UK, Germany & USA), design and change control, audits; Experience of government and international requirements including FDA 21 CFR 820, 21 CFR 11, MDD 93/42/EEC (2007/47/EC), 2006/42/EC, CMDR SOR/98-282, ISO 13485, ISO 9000, ISO 14001, IEC 60601 (series), IEC 62366, BS EN 980, BS EN 1041, 2003/108/EC (WEEE), knowledge of sterilization and biocompatibility standards, ISO 14971, REACH, RoHS and JPAL.
18 June 2012: IT’sQA announces their collaboration with KCS, a software company and part of the Malam-Team - the largest and the leading IT services group in Israel. Headquartered in the Science Park Rehovot, Israel, KCS has an impressive client base comprising dozens of leading global Pharmaceutical companies, well known banks and large public corporations. Through this collaboration IT’sQA will support their auditing and the IT’sQED™ Quality Management System (QMS) services with this validated system and expand their services to resell, design, customise, and project manage the deployment of the KCS electronic QMS Generica™ to clients looking to implement an electronic QMS in their companies.
25 May 2012: IT'sQA and A-Square Healthcare Ventures, a boutique healthcare consulting company based in India are pleased to announce their partnership venture "IT'sQA Asia". As a result of this partnership, IT'sQA & A-Square will further strengthen their quality related services under the banner of IT'sQA LLP, with the set-up of a new affiliate in the Asia-Pacific region bringing over a decade of clinical research expertise with Big Pharma in the Asia-Pacific region.
08 March 2012: IT’sQA announces the formation of a dedicated, International Pharmacovigilance QA (PVQA) Group; IT’sQA-PV with PVQA consultants based in Japan, India, Australia, UK and Canada with proven experience of PVQA in Japan, US, Italy, Sweden, Denmark, Australia, New Zealand, UK, Spain, India, Germany, Korea, Indonesia, Taiwan, Singapore, Belgium, France, Canada, Vietnam, China.