GxP Readiness

Our services extend right across the product development lifecycle – from raw materials/device 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

What Rephine Offers

REPHINE AUDIT BLUE PREP INSPECTION ICON

Preparation of Inspections

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 wide experience working both with pharmaceutical laboratories and directly with the main actors involved in the supply chain, allows us to address different risk management strategies and to easily respond to issues.

REPHINE AUDIT BLUE QMS DEVELOPMENT ICON

Good Clinical Practices and Pharmacovigilance

Our experience in GCP and GVP has supported clients in the changing pharmaceutical industry. Many companies are constantly filing drug applications for new medicines and new markets for existing medicines

Training services

We offer a a range of training sessions in different formats: in person and online

All the modalities are taught by professionals with extensive experience in each of the subjects covered, both from the technical and regulatory point of view.

 

Meet the GxP Experts - Equipment Qualification

Equipment Qual team
Anna Cluet headshot (1)

Anna Cluet

Senior Consultant/GMP Consulting Area Manager

Silvia Cano headshot

Silvia Cano

 Senior Consultant/Equipment Qualification Area Manager

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.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library

REPHINE PURPLE ACCENT POST SUBM LIFECYCLE ICON

Digitalisation

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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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REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

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