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.
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