GxP Consultancy

We help drug and device manufacturers bring the best possible product to market, in full and demonstrable compliance with the latest GxP standards

Our comprehensive suite of consulting and advisory services includes quality management systems, mock inspections, equipment qualification/computerised system validation, and plant engineering assessments.

Consulting & advisory services

We are product quality experts, serving the strictly regulated life sciences industry – encompassing pharmaceutical, biotech and medical device manufacturing supply chains globally.

Our services extend right across the product development lifecycle – from raw materials/device components to patient delivery.

We offer a complete suite of services, which we can customise to suit the specific needs of our clients

GxP Consultancy Services

Computer Systems Validation

We ensure our customers deploy high quality, compliant technology systems while maintaining and assuring data integrity.

Whether on-premise or cloud, waterfall or agile or something in between, our experts have validated systems across the value chain including labs, pre-clinical, clinical, regulatory, quality, manufacturing, supply chain and ERP.

QMS Advisory

Our Quality Management System (QMS) Advisory service helps our customers to achieve a systematic approach to Quality design and maintenance, and optimised business processes.

We can also deploy the TrackWise Digital Quality Management Software – a digital ecosystem to drive proactive quality across the supply chain, in addition to other QMS software technologies such as Veeva, Ennov and others.

Our QMS experts can also advise on the opportunities for digital transformation across GxP processes to ensure maximum impact.

GxP Readiness

We assess and target improvements as needed across all contributory manufacturing systems, processes, materials/products and manufacturing plants, to ensure there are no gaps in quality or compliance, across all phases of the site and product development, and manufacturing lifecycle.

Medical Devices

For the fast-expanding field of medical devices – encompassing smart/digital devices as well as health tracking apps and software as a medical device.

Our tailored service follows the latest global regulatory frameworks and manufacturing requirements specific to this sector.

Companies across multiple industries use TrackWise to increase efficiency, improve quality, meet compliance commitments and reduce risk.

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

GMP Audit Services

GxP Consultancy

Global Audit Library

Digitalisation

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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.

Email: [email protected]

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