Services
VI.REL PHARMA takes care of the whole life-cycle of medicinalS, of medical devices and of food supplementS, includING:
REGULATORY AFFAIRS
Scientific consultancy in the development process
Interaction with the European Medicines Agencies and the EMA
Scientific Advice assistance
Assistance in the designation of orphan drugs
Planning and budgeting for the registration process: support in the implementation of the most efficient regulatory approach
Document writing
Editing of European dossier CTD: editing of Module I and II (medical writing for nonclinical and clinical overviews and summaries), assistance in compiling of Modules 4 and 5
Product management: updating, variations and renewals (editing of Addenda to the Clinical Overview)
Life-cycle management during European procedures (MRP and Centralized)
PHARMACOVIGILANCE
QPPV support, support and consultancy for QA activities in Pharmacovigilance (including PSMF management and associated SOPs)
Registration with EudraVigilance
Population of Article 57 database
Reporting and medical assessment of ICSRs
EDUCATION
On-site training on Regulatory Affairs and Pharmacovigilance
NON-PHARMACEUTICAL
Support for Medical devices/Food Supplements