In the changing pharmaceutical industry, companies are constantly filing drug applications for new medicines and new markets for existing medicines
This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs).
Good Clinical Practice
Pharmaceutical Industry should ensure that the requirements of Good Clinical Practice (GCP) are met, as well as the correct management and statistical processing of the associated data
Once the medicine is in the market, it is necessary to have a Pharmacovigilance system to properly manage the adverse events detected, in order to effectively detect and evaluate all potential problems. The Pharmacovigilance system should have an adequate Quality Management System and organization, as well as well-established processes to ensure compliance with Good Pharmacovigilance Practices (GVP).
This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs), often located in many different countries.
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.
Cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered medical devices
Rephine and Eurofins are acting against substandard audit practices with guarantees of the highest quality of inspection services & library reports, from raw materials to
A few weeks ago, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for
Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions. Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in
About this Case Study The case study involved a pharmaceutical company seeking to bring a product, manufactured in Europe, into the US market for commercialisation.