Regulatory advice and strategies

Active support in the build-up of regulatory dossier, particularly in administrative documentation, expert reports, summaries, SmPCs, leaflets & labeling, certifications, etc.

Direct handling of administrative procedures for marketing authorizations via national, mutual recognition or decentralised route, including their variations, renewals, withdrawal of suspension and revision

Day-to-day liaisons with Government bodies to follow the filed applications (the company location is relatively close to Drug Agency offices in Rome)

Support in regulatory compliance to promotional activities, pharmacovigilance and clinical trials

Pricing and reimbursement issues: drafting of dossiers for admission to reimbursement and assistance in price negotiations with the Authorities

Notification/marketing authorization of food supplements, medical devices and biocides

Technical and regulatory auditing of registration dossiers for licensing purposes

Brokerage of products/dossiers, technologies and patents originated by private companies or discovery organizations: identification of potential licensees for clients' own products / identification of in-licensing opportunities fitting with the clients' specified requirements

Support for manufacturing authorizations of new sites and extension applications for existing sites

Assistance for DMF filing to Italian Authorities

Selection of local production sites for contract manufacturing agreements; assistance for compliance with newly issued national rules on traceability of medicinal products

Assistance in negotiations with local companies for all the above purposes