GxP Readiness

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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 

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Inspection Preparation

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

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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

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Process Validation

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

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QMS Development

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

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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

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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
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Anna Cluet

Senior Consultant &
GMP Consulting Area Manager

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Silvia Cano

Senior Consultant &
Equipment Qualification Area Manager

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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.

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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

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GMP Audit Services

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

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GxP Consultancy

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

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Digitalisation

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

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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.
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