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

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 span the entire product development lifecycle, from raw materials and device components to patient delivery, providing a seamless continuum of support.

We tailor our offerings to meet the distinct requirements of each client, by offering a comprehensive suite of consulting and advisory services, including quality management systems, mock inspections, equipment qualification, computerised system validation, and plant engineering assessments.

Why choose Rephine?

REPHINE AUDIT BLUE REMEDIATION ICON

Digital Mindset

We harness technological transformation to achieve good practices in manufacturing and beyond (GxP), and to progress risk management and industry sustainability

REPHINE AUDIT BLUE HIGH STANDARDS ICON

High Industry Standard

We maintain a continuous and fluent relationship with local and international organisations related to GxP compliance and validation

REPHINE AUDIT BLUE COMMITMENT INNOVATION ICON

Innovative and Flexible

We specialise in complex and strategical projects that require critical thinking and ground-breaking tailor-made solutions

REPHINE AUDIT BLUE HANDSHAKE ICON

Long Term Relationships

We are a strategic partner and as such our clients rely on our expertise and commitment to deliver the best results overtime

Discover our suite of GxP Consultancy Services

GxP Readiness

Identify and enhance manufacturing systems, processes, and products to ensure compliance and quality throughout product development and manufacturing.

Pharmaceutical,Industry.,Production,Line,Machine,Conveyor,With,Glass,Bottles,Ampoules
Engineer servicing server rows

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 are also partners of premier QMS software technologies and digital ecosystem solutions to drive proactive quality across client’s supply chain. Our QMS experts can also advise on the opportunities for digital transformation across GxP processes to ensure maximum impact.

Doctor working on computer
close up chief researcher scientist adjusts microscope time coronavirus experiment

Medical Devices

For the fast-expanding field of medical devices, encompassing smart and 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.

GxP Consultancy

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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Related Resources

GMP Design Review Guide header image CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
mock inspection blog header Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.
Read More
GSPR MedTech guide header image CSV

Essential Guide to EU GSPR Compliance for Medical Devices

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Cloud systems maintenance guide header image CSV

Maintaining Cloud Systems – A Continuous Effort

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Close up of nurse holding and typing on tablet Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...
Read More
Tim Hawkins PR Header Image (2) Company News

Tim Hawkins Joins Rephine as CEO to Spearhead Global Leadership

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...
Read More
Robert Nurse Chief Growth Officer Company News

Rephine appoints Quality Assurance expert Robert Nurse as Chief Growth Officer

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...
Read More
Doctor Article

Maintaining Data Integrity with Digital Validation

The importance of data integrity is a widely discussed issue. There has been a rise in regulatory bodies like the FDA and WHO auditors focusing ...
Read More
Femtech Header Blog

Shaping the Future of Femtech to Inspire Inclusion and Innovation

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.
Read More

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]
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us