"Always do more than is required of you."
- George S. Patton -
REGULATORY AFFAIRS
Regulatory support is provided on Drug Products (Human and Veterinary), Medical Devices, Food Supplements and Food for Special Medical Purposes.
Human and Veterinary medicinal products
- Marketing Authorization submission strategy in complex scenarios
- Feasibility studies
- Due diligence and strategic support on companies/portfolio acquisition
- Due diligence on registration dossier
- Marketing Authorization submissions, Variations and Renewals (for Decentralized/MR and National procedures)
- Full CMC expertise, human and veterinary, EU and USA
- Technical writing (module 2.3 and module 3, IMPD)
- Medical writing (modules 2.4, 2.5, 2.6, 2.7 and translations IT-EN and EN-IT)
- Product Information writing
- Start-up of a pharma company (Italy)
- Full regulatory support on Italian Marketing Authorizations:
- SIS code and CUA applications
- Digital domicile and certified email
- Local Representative and Concessionario notifications
- Marketing Authorization applications and maintenance
- eCTD publishing
- Marketing Authorization tranfers
- AIFA FrontEnd portal management
- Digital signature recognized on FrontEnd
- Promotional materials and Scientific Information
- Congresses
- Farmastampati, Bozen Databank, Compendia, local OJ publication
- Traceability related tasks (anti-counterfeiting)
- Proxy and Digital domicile towards AIFA
- CPP request (Certificate of Pharmaceutical Product)
- Decrees retrieval at AIFA (Rome)
- Price and Reimbursement (in partnership with local experts)
- Advice on Regulatory department organization
- Regulatory Intelligence
Medical Devices
- Proxy towards Italian Ministry of Health
- Support from feasibility analysis to CE marking
- Italian databank: registration and maintenance (Manufacturers and Medical Devices)
- Promotional Materials of Medical Devices: set-up, review, submission till approval
Food Supplement and Food for Special Medical Purposes
- Notification onto Ministry of Health databank
- Free sale certificates
