Medical Devices

The team has considerable experience in providing strategic advice for the launch of new devices, with detailed knowledge of ISO 13485. We have prepared and managed a number of technical files on behalf of clients.

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Iolite Pharma Consulting

Iolite Pharma Consulting offers a unique combination of Quality Assurance and Regulatory Affairs expertise, supported by considerable senior management experience. We offer interim management and bespoke consultancy services.

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Quality Assurance Consultation

We are highly experienced Quality professionals and offer advice on a wide range of strategic and operational issues, small and large. We are experienced in Pharmaceuticals (Commercial, Investigational, Human and Veterinary Medicinal Products) Medical Devices. We also provide contract Qualified Person and Responsible Person services.

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Inspection Preparation and Remediation

We have prepared for, hosted and responded to numerous regulatory inspections – with experience of EU, US, Australian, Japanese, Chinese and other international requirements.

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Regulatory Affairs

We work with a number of experienced regulatory professionals, able to advice on regulatory strategy, process and expectations. Our Associates include ex-MHRA Assessors.

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Interim Management

We undertake senior level interim roles – having worked with small and large companies, many in the Contract Development and Manufacturing Sector. We specialise in providing leadership for organisational change management and organisational design initiatives.

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Medical Devices

The team has considerable experience in providing strategic advice for the launch of new devices, with detailed knowledge of ISO 13485. We have prepared and managed a number of technical files on behalf of clients.

Find out more

Iolite Pharma Consulting

Iolite Pharma Consulting offers a unique combination of Quality Assurance and Regulatory Affairs expertise, supported by considerable senior management experience. We offer interim management and bespoke consultancy services.

View services