Providing medical-regulatory advisory services for Pharmaceutical Companies and Medical Devices' Legal Manufacturers.www.pharmalogics.pl

Providing medical-regulatory advisory services for Pharmaceutical Companies and Medical Devices' Legal Manufacturers.www.pharmalogics.pl

Medical-regulatory advisory services for Europe, Middle East and Africa regions, including:Expert reports and expert opinions review and preparation, coordination of external experts services (CTD Modules 2, 4 and 5)Assessments and opinions regarding strategies of medicinal products registrations and geo-expansion;CTD dossiers (medical part) internal and external auditing; Clinical sites auditing (GCP, overall compliance)Preclinical and clinical studies (including Phase III) designing, protocols reviewConducting of internal trainings for SalesReps and RA department;Review and acceptance of local and EU core marketing materials for products assignedSupport for local Medical Information Managers in complicated or challenging queriesSOPs reviews and updates

Medical-regulatory supporting services for Poland and Europe, including:Expert reports and expert opinions review and preparation, coordination of external experts services (CTD Modules 2, 4 and 5)Assessments and opinions regarding strategies of medicinal products registrations and geo-expansion;CTD dossiers (medical part) internal and external auditing; Clinical sites auditing (GCP, overall compliance)Preclinical and clinical studies (including Phase III) designing, protocols reviewConducting of internal trainings for SalesReps and RA department;Management of CRO's offers for preclinical and clinical studies;Review and acceptance of local and EU core marketing materials for products assignedMedical Information service for Company's productsProduct Information maintenance and updateCCDS preparation and update

Bioequivalence studies planning, monitoring and clinical documentation/reports evaluation;Phase-III and Pre-certification efficacy/safety studies designingClinical Sites audits (both in bioequivalence and efficacy/safety studies)Conducting of internal trainings for medical and CMC staff;Project managing (FDC medicinal product and innovative medical device)Expert reports and expert opinions preparation (e.g. CTD Modules 2.4, 2.5, Benefits/risk evaluations for PSURs).Clinical Evaluation Reports preparation for Medical Devices together with literature search reports according to MedDevPreparing of assessments and opinions on the possibility and strategies of medicinal products registrations;PSURs preparation and other PhV-related activities (e.g. periodic database search);Registration dossiers (medical and administrative part) internal and external auditing; Preclinical studies designing, Scientific Advice documentation preparation;