GxP Readiness

close up scientist looking through ocular lens LR

Comprehensive support for your product lifecycle

Our development services extend from raw materials and devices components to patient delivery

We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems for over 25 years, so rest assured we’ve got you covered.

We provide versatile support across a range of expertise 
from our in-house professionals 

REPHINE AUDIT BLUE PREP INSPECTION ICON

Inspection Preparation

The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives

REPHINE AUDIT BLUE COMMITMENT INNOVATION ICON

GxP in R&D

Improving both product and process understanding, in combination with quality risk management, will support the establishment of an appropriate control strategy for consistent product quality and improved process performance

REPHINE AUDIT BLUE QUALITY TICK ICON

Process Validation

The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality

REPHINE AUDIT BLUE REMEDIATION ICON

QMS Development

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

REPHINE AUDIT BLUE SERVICE OFFERING ICON

Good Distribution Practices

Rephine's experience with pharmaceutical labs and supply chain stakeholders enables us to craft effective risk management strategies and address challenges promptly

REPHINE AUDIT BLUE QMS DEVELOPMENT ICON

GCP and GVP

Our expertise in Good Clinical and Pharmacovigilance Practices supports clients in the dynamic pharmaceutical industry, assisting companies in filing drug applications for new and existing medicines across diverse markets

Comprehensive Training Services

We offer a range of training sessions in different formats, catering to your requirements

All modalities are instructed by our in house professionals through either in-person or online sessions. Our experts have extensive experience in each covered subject, encompassing both technical and regulatory perspectives, ensuring your enterprise is well-prepared at any stage of the ecosystem.

Meet the GxP experts in Equipment Qualification

Our experienced team of Equipment Qualification consultants act as a partner ensuring regulatory compliance and quality assurance. We are driven by our enthusiasm to bring safe, effective and innovative equipment to market.

Equipment Qualification Team
Anna Cluet headshot (1)

Anna Cluet

Senior Consultant &
GMP Consulting Area Manager

Silvia Cano headshot

Silvia Cano

Senior Consultant &
Equipment Qualification Area Manager

MD audits.png

Need to discuss about a project? We are only one discovery call away.

We offer free 30 minute discovery calls so we can understand your QA requirements for any project. Whether you're just starting out, or an established enterprise, we've got you covered.

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

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
3PARL QUALANDRE HEADER Article

3PARL® Consortium grows stronger with Qualandre’s emphasis on ethical conduct and trustworthiness

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
Read More
Unrecognizable lab worker inspecting blood sample under microsco Blog

Innovative Solutions for Cancer Diagnosis and Prevention

As we navigate the complexities of cancer care, there’s a shared commitment to driving change and ensuring equitable access to life-saving treatments. This year’s World ...
Read More
3PARL OWLPHARMA BLOG HEADER 1@300x Article

Owlpharma joins 3PARL® to propel mission for ethical GMP supply chains in Life Sciences

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
Read More
Scientist chemist researcher doctor analyzing dna sample using medical microscope GxP Consultancy

Decoding the technological minefield – A tactical approach to maximising Life Sciences R&D Software implementations

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Engineer servicing server rows Blog

All change for computer software assurance in Life Sciences

Newly published FDA guidance on Computer Software Assurance (CSA), together with the second edition of the GAMP 5 guide, have shifted the emphasis away from ...
Read More
3PARL PHARMA AUDIT BLOG HEADER LR Article

Pharma Audit among newest members of the recently launched initiative 3PARL®

3PARL® consortium welcomes Pharma Audit in its mission to assure consistent high standard of GMP supply chain audits in the life sciences industry   Stevenage, ...
Read More
Clinical Trials Blog LR Blog

Navigating ICH E6 (R3) changes for GCP excellence with a digitalised QMS process

In the realm of clinical research, adhering to Good Clinical Practice (GCP) through the ICH E6 guidelines has become an essential part for global 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                               

Newsletter