Due diligence and gap analysis of regulatory dossiers Analysis of existing documentation, applicable norms assessment, support in the preparation of the documents to submit to the Italian authorities.
Applications for Marketing Authorizations
NATIONAL, MRP, DCP
Scientific pre-launch
Brand strategy and life-cycle management
Product relaunching planning
MA Variations
Type I and Type II in e-CTD sequence
Follow-up of Centralized Procedures (CAP)
MAH Transfers
MA Extensions
MA Renewals
Sunset clause
MA Withdrawals
Certificate of a Pharmaceutical Product (CPP and eCPP)
Importation, parallel distributiom
Finished Product (MED)/Active
Pharmaceutical Ingredient (API) manufacturing sites and GMP Certification
Inspection Follow-up and CAPA management
Regulatory assessments of Active Pharmaceutical Ingredients (APIs)
HTA – Pricing and reimbursement negotiation procedures
Dossier preparation;
HTA Assessment and therapeutic positioning
Market analysis, sizing, forecasting, business cases, complex medicines in Oncology, Endocrinology, Hematology
Readability tests of the Package Information Leaflet
Preparation of promotional materials, medical writing
Proofreading of promotional materials
Management and support for healthcare advertising of OTC/SOP products
Study planning: Ph lllb/IV, RWE, registries, observational studies
Request and management of Scientific Advice
Text drafting and publication in the Italian Official Journal
Request management and online portal support for the "Bollino" system
