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
The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives
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
The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality
We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems
Rephine’s experience with pharmaceutical labs and supply chain stakeholders enables us to craft effective risk management strategies and address challenges promptly
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
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.
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.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
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
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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