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 Quality Assurance services includes mock inspections, equipment qualification/computerised system validation, and plant engineering assessments.

Consulting & advisory services

Our global experts support clients on the best option to fulfil their GxP requirements.

Including:

GxP readiness services – assessing and targeting improvements as needed across all contributory manufacturing systems, processes and materials/products, to ensure there are no gaps in quality or compliance, across all phases of the product development and manufacturing lifecycle.
Digital transformation of manufacturing controls, including the addition or introduction of modern, robotic capabilities – our ability to validate systems and ensure data integrity within those new processes, ensure maximum impact.
For the fast-expanding field of medical devices – encompassing smart/digital devices as well as health tracking apps – our tailored service follows the latest regulatory framework and manufacturing requirements specific to this sector.
Our Quality Management System (QMS) advisory service helps our customers to achieve a systematic approach to Quality design and maintenance, and optimised business processes.

Computer Systems Validation (CSV)

We have a team of international consultants with extensive knowledge of the technologies and computer systems used in the pharmaceutical industry.

QMS Development

We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems

Trackwise

TrackWise® created by Sparta Systems, is the most trusted Enterprise Quality Management System (EQMS).

Medical Devices

Rephine provides innovative and scalable solutions to meet the quality and compliance requirements of the Medical Devices sector

Equipment Qualification

Our experience in the qualification and commissioning of facilities and equipment is backed by years of successful inspections and audits

GMP Compliance

We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems:

Digital Validation - Valgenesis

Coming Soon

Training

Rephine offer our customers training sessions in different formats: in person and also online

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 & Regulatory Compliance, we’re the partner of choice for all the stakeholders we deal with.

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

GMP Audit Services

GxP Consultancy

Global Audit Library

Regulatory

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