Pharmacovigilance System Set-UpQPPV Office & PSMF ManagementLPPVs & Local PV ServicesLiterature ScreeningPV Regulatory IntelligenceSafety Data ManagementClinical Safety ServicesMedical Monitoring Services

Outsourced LQPPV services for Kenya ,Uganda, Tanzania, Uganda, Ethiopia, Rwanda, Malawi,Zimbabwe ,Mauritius,Sudan.Medical information call centre (MICC)ICSR management SOP generation and ManagementPV quality system management PV audits and Capa management

Management of local QPPVsPharmacovigilance System master filePharmacovigilance Trainingsignal detections PBRER management Risknmanagement plansREgulatory intelligenceLiteratur screening website screening ICSR processing Phrmacovigilance audits

Management of local QPPVsPharmacovigilance System master filePharmacovigilance Trainingsignal detection PBRER management Risk management plansRegulatory intelligenceLiterature screening website screening ICSR processing Pharmacovigilance audits

Drug registration, medical device registration, regulatory strategy , clinical trials , product retentions and renewals , marketting Authorization applications , regualtory authority engagements

Regulatory affairs is a major determinant of early market entry and maintainance of postauthorization compliance . To remain compliant in the most efficent way , its prudent to engage a competent regulatory affairs professional . Regulatory affairs includes key processes like Product registrations (dossier compilation, audit and marketing authorizastionappliccations ), GMP audits and inspections , post approval renewals and variations , management of promotional materials and Risk minimization acticvities and various Communications with the health authorities . Postmarket surveillance , also known as pharmacovigilance is part of the epected compliance activites . Dr Jerusha , with almost a Decade of Regulatory affairs and pharmacovigilance expereience across Africa will be your go to pharmacist for this key function. In tandem with the current global trends , business process outsourcing is proving to be reliable and cost effective . In line with this, Dr Jerusha is Leading a team of experienced consultants at Jeyflex consultants to offer Bespoke regulatory affairs and other compliance services, for more information visit us at https://jeyflex.com/