Testimonials

Angela Robertson

Group Regulatory Affairs Director, Omega Diagnostics Ltd

Omega Diagnostics has utilized CHIARA Regulatory Consultancy Services Ltd over the past four years to support a busy regulatory department during rapid growth within our IVD manufacturing organization.

Lesley has provided both regulatory and clinical expertise to ensure that performance evaluations for new products are undertaken to meet CE marking, WHO requirements and other regulatory jurisdictions and has also been invaluable in reviewing and approval of product development verification protocols and reports. Lesley has also provided regulatory support to our IVDR transition project, including undertaking literature reviews and gap analyses of product analytical performance and clinical data.

Lesley is a very experienced and knowledgeable regulatory and quality professional and works to the highest quality standards and I am confident in Lesley’s abilities to provide support for any IVD/medical device regulatory, clinical or quality requirements.

Mike Izon

R&D Director, Tissue Regenix Ltd

Lesley has an outstanding ability to turn underperforming device companies into compliant and effective businesses. I have previously worked with Lesley when I was a consultant and she was appointed as Quality & Regulatory Affairs Manager. Lesley was able to quickly identify the major compliance issues and translate this into a working improvement plan based on the main compliance risks balanced with a desire for long term quality and regulatory improvement. Ultimately the plan was delivered and the business continued to develop and improve in key quality and regulatory compliance areas. I would recommend Lesley as a highly experienced and capable Quality & Regulatory Leader.

Collette McGregor

Head of Quality, Merck Millipore (UK) Ltd

Lesley is very knowledgeable in both quality and regulatory matters and I found her to be very hard working and conscientious in her role. Lesley is very personable and builds solid working relationships by being open, honest and approachable. Lesley can easily focus in on what needs to be done in order to prioritise and complete projects thoroughly and on time.

Albert Nicholl

Chairman, Gendius Ltd

Lesley Paice has been engaged by Gendius Ltd to perform advisory services and to assist the company to prepare the regulatory path to enable the company to prepare a Regulatory Strategy Document for classification for submission to MHRA. MHRA classification opinion in writing. Technical Documentation and QMS tasks. Regulatory strategy plan for EN ISO 13485:2016 and additional CE marking tasks for product classified as Class IIa.

Lesley was engaged to do this work because of my experience working with her as she performed similar duties for another of my portfolio companies (Freedom One Life)

Lesley is, in my opinion highly skilled and qualified for the services she provides through her company. I have no hesitation in recommending her.

Cheryl Lockett

Managing Director, Blue Vector Ltd

Whilst Lesley was at Hyaltech, I worked as a medical device regulatory consultant with her, on a number of projects. Lesley is highly professional, with wide-ranging expertise in medical device regulations and quality assurance. It was a pleasure to work with her.

Liz Blake

SPD Swiss Precision Diagnostics GmbH

Lesley has led many regulatory projects that I’ve been involved in. She’s extremely knowledgeable and is excellent at pulling a team together. Lesley’s experience of regulatory requirements and procedures has minimised the business impact of any investigations or recalls.