GxP Readiness
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.
Inspection Preparation
The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives
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
Process Validation
The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality
QMS Development
We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems
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
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.
Anna Cluet
Senior Consultant &
GMP Consulting Area Manager
Silvia Cano
Senior Consultant &
Equipment Qualification Area Manager
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.
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.
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
GMP Audit Services
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
GxP Consultancy
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
Digitalisation
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
Related Resources
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REPHINE CHINA
- Shanghai, China
REPHINE INDIA
- Hyderabad, India