Danielle Iwandza

When it comes to drug safety, PharmaCqARE is a reliable partner to the pharmaceutical industry. We are a pharmacovigilance focused consultancy delivering advisory and outsourcing solutions to the pharmaceutical and medical sectors. We take care of everything – from preparing PSURs, RMP, eCTD to developing complete pharmacovigilance systems. All our experts have between 18 to 25 years of experience in the European pharmaceutical industry with experience in some Third markets. Our fields of expertise : - Pharmacovigilance Management of case reports, identification of signals, writing of Safety Reports and Risk Management Plans Outsourcing of EUQPPV/Deputy EUQPPV, Local PV Responsible Person / Local deputy PV Responsible Person - GxP Audits Audit of systems, structures and dossiers in line with the Good Practices, proposal and implementation of preventive and corrective actions until completion (GMP, GDP, GCP, GVP) - Quality Assurance Good practices and Quality control performed based on ICH Requirements (US, Europe, Japan) and international norms of reference - Regulatory affairs Assessment of Registration or Clinical Trials application dossiers, any approval dossiers, writing of regulatory documents and handling of variations. - Training Trainings on Pharmacovigilance, Clinical Trials, Quality Assurance, Regulatory Affairs and other specific matters. Trainings can an be provided through e-learning (MyTraining), virtual classroom or face-to-face at PharmacQare HQ or at client site. - Customized services - Monitoring & Medical Monitoring during Clinical trials - Communication Proposals, support and consulting in any drug-related communication campaign. Please contact us for more information and quotation !