We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems
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 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.
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
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.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.