Case Studies

Turning audit prep into continuous improvement with Compliance Intelligence

Qualio — Mon, 10 Nov 2025 09:47:01 GMT

AGADA Biosciences provides expert assistance with drug development programs from its base in Halifax, Nova Scotia.

5x return on investment with Compliance Intelligence

Qualio — Tue, 04 Nov 2025 15:45:38 GMT

UK-based LogixX Pharma specializes in the commercialization of life science products, marketing and distributing a range of innovative pharmaceuticals, nutraceuticals and medical devices.

How Sentec cut audit prep 80% with Compliance Intelligence

Qualio — Wed, 08 Oct 2025 09:29:48 GMT

Sentec is a Swiss-American medical device company specializing in respiratory care and non-invasive monitoring.

The company sells its medical device products across the globe, juggling simultaneous compliance with some of the toughest regulatory standards in the world, including the EU MDR and the MDSAP.

Empowering a start-up to take on a regulated market

Qualio — Mon, 23 Jun 2025 08:53:45 GMT

Mindstep is a digital front door platform for mental health and mental fitness, leveraging AI to provide clinical assessments, care, and onwards care navigation.

Impressing auditors and maintaining ISO 13485 compliance

Qualio — Tue, 17 Jun 2025 08:24:47 GMT

Tamer Mölnlycke Care is a joint venture between the Swedish Mölnlycke Healthcare and the Tamer Group, based in the latter's native Saudi Arabia. The venture, launched in 2021, represents an ambitious mission to bring a host of new medical devices and healthcare products to Saudi Arabia.

Hitting new heights of clinical quality with Qualio

Qualio — Tue, 25 Feb 2025 09:57:53 GMT

The Wellcome-HRB Clinical Research Facility (CRF) is a state-of-the-art clinical research partnership between Saint James' Hospital and Trinity College Dublin. From its research pharmacy to its aseptic compounding suite, the facility specializes in delivering clinical trials with optimal standards of quality and regulatory compliance.

Quality excellence for a medtech consultancy - and their clients

Qualio — Fri, 26 Jul 2024 11:33:52 GMT

Switzerland-based Effectum Medical offers a hands-on, collaborative partnership to help its medical device customers innovate and embed lasting compliance with the requirements of ISO 13485, the FDA, and the EU's MDR and IVDR.

Expression Therapeutics optimizes document management with Qualio

Qualio — Fri, 26 Jul 2024 08:30:07 GMT

Expression Therapeutics, Inc. is a fully integrated clinical stage gene and cell therapy company developing novel, potentially curative, therapeutics for deadly childhood and adult genetic diseases.

VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

Qualio — Fri, 26 Jul 2024 08:29:52 GMT

VitaCyte is a biotechnology company that manufactures high-purity tissue dissociation enzymes and cell recovery reagents, including collagenase. The company’s product portfolio is designed to correlate optimal enzyme activity with specific cell and tissue types to maximize viable cell yields. VitaCyte, which was founded in 2004 and is headquartered in Indianapolis, has 11 employees.

Positioning a biotech start-up for long-term success

Qualio — Mon, 25 Mar 2024 14:34:37 GMT

Enara Bio is a UK-based biotech start-up pushing the boundaries of cancer immunotherapy.