Recent projects and updates
A European generics company had received three Major findings at a recent Pharmacovigilance inspection. The CEO believed that commercial operations were at risk if remedial actions were not taken prior to the re-inspection. After radical review, restructuring of operations and essential client training, the repeat inspection passed without any Major or Critical findings. The inspectors reported they were delighted with company’s improvement.
Our client, a global pharmaceutical company headquartered in Europe, requested we provide a review of all copy approval practices for a European subsidiary. There had been an infringement of national codes by one subsidiary. A full review showed many areas of poor understanding and miscommunications between Medical Information, Marketing, Sales and Personnel responsible for Medical Certification. Our recommendations were accepted in full and one of our team was recruited full-time to lead the Marketing Code Compliance unit.
A pan-European Reimbursement and Pricing review was required by a US client. France, Germany, Italy, Spain and UK were targeted. Over 40 face-to-face interviews were conducted across Europe. Details of policy and practical details of how they were enacted in one particular therapeutic area were discovered. Country-country as well as in-country variation were highlighted. Marketing teams within the client were surprised by the high level of detail discovered. The results are being used to inform pricing strategy across Europe.
Conflicting advice had been given by a European Regulations Agency. Additionally a product had received marketing approval in Australia and it was questioned whether this would persuade European regulators to grant a licence in the EU. A contractor was sourced and provided with deep experience of this type of dilemma, having worked in appropriate regulatory agencies. Concise, pragmatic opinion was given enabling decision-making by senior management.