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 Raising the bar Blog series Header image May 25 Article

Effective QMS Management Post-Go-Live: Strategies for Governance, Releases, and Continuous Improvement

After QMS go live, compliance and performance depend on strong governance, structured release management and continuous improvement. Learn how to sustain control, adoption and long ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

GMP Consultancy for a New Manufacturing Plant

With only a small team and a highly automated process, this biotech company needed to achieve EU GMP compliance fast. This case study shows how ...
Read More
CPV Header image case study apr 25 CSV

EU GMP Draft Updates Explained: Chapter 4, Annex 11 and the New Annex 22

This expert Q&A session explores the draft EU GMP updates to Chapter 4, the revised Annex 11 and the new Annex 22 on Artificial Intelligence. ...
Read More
ICH E6 Guide Header Image (1500 x 844 px) Article

Why Quality Can No Longer Live in Silos

Discover why siloed quality management is no longer sustainable in life sciences. Learn how integrating audits, advisory services and digital quality systems supports continuous GxP ...
Read More
QMS IMP Header image Blog case study May 25 Article

Why Most QMS Implementations Fail to Deliver Long-Term Value

Implementing a QMS is more than deploying software. Learn why most QMS implementations fall short, and what successful life sciences teams do differently to achieve ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

Driving Global QMS Harmonisation for a Pharmaceutical Company

This case study outlines how Rephine helped a global pharmaceutical group implement and validate a harmonised Quality Management System across more than seventy sites. It ...
Read More
Banner Resource Hub Web Guide

How to Structure MDR Technical Documentation (Annex II & III). A Practical Compliance Guide

This white paper provides a practical guide to structuring MDR Technical Documentation under Annex II and Annex III. It explains how to organise evidence, maintain ...
Read More
CSV Blog

IT Quality Assurance in Regulated Life Sciences: Key Insights

IT Quality Assurance is pivotal in regulated life sciences. From CSV and data integrity to change control and audit readiness, discover how IT QA ensures ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan General

Practical compliance and inspection readiness for UK pharmaceutical quality systems

Explore how UK pharmaceutical and biotech organisations can stay prepared for MHRA, EMA and FDA inspections. This session provides expert guidance on inspection trends, compliance ...
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.
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards