The proficient implementation of the comprehensive and complex regulatory environment into your company’s own system – focusing on the essentials – facilitates a higher level of safety and provides you with more freedom to focus on the development and marketing of effective and efficient medicines and medical devices; that’s what BoosConsulting is dedicated to every day – for the safety of medicinal products, the safety of medical devices, and ultimately the patient’s safety.
Range of services
Dr. Monika Boos LL.M. supports you in the pharmacovigilance of development compounds and established products (e.g. setting up a PV system, EU QPPV / Graduated Plan Officer, implementation of national / European / global PV requirements, preparation and follow-up of Authority Inspections / internal PV Audits); further key areas cover medical devices (vigilance, clinical evaluation, distinction issues) and pharmaceutical law matters.