Del Corno & Associati - Regulatory Consultancy Services for the Pharmaceutical Industry

Del Corno & Associati provides regulatory consultancy services to the pharmaceutical industry, including developing and obtaining the appropriate authorizations to market medicinal products, medical devices and food supplements.

The company provides the ultimate experience in regulatory compliance to Italian and European HA requirements for both registration and compliance.

Regulatory consultancy for submission of registration dossiers

Thanks to our extensive expertise in the field of regulatory consultancy, we can support regulatory filings, pharmacovigilance and CMC compliance. Del Corno & Associati provides a dedicated and flexible service.

Del Corno & Associati works with a wide range of clients: large multinationals, small start-ups, third-party manufacturers, CROs and device manufacturers.

The services we offer range from regulatory consultancy for the writing, preparation and submission of registration dossiers, to the ‘due diligence’ and management of the submission during the whole process.

Drug approval and regulatory support

Del Corno & Associati takes care of the whole drug approval process, including:

• Time and cost planning for regulatory activities: from regulatory support to advising the most convenient regulatory approach
• Regulatory support to developing companies
• Writing of EU CTD dossiers, including preparation of NeeS and e-CTD dossiers
• Lifecycle management of medicinal products: updates, variations and renewals
• National and European registration and maintenance procedures (MRP and centralized)
• Due diligence activities: licensing support
• Pharmacovigilance
• Pricing and reimbursement criteria at the Italian national level
• CTA applications for every clinical trial phase (phase I-IV) in Italy
• The company has credits with the Agenzia Italiana del Farmaco for the submission and registration of products (operating code SIS)

Dossier reformatting for Common Technical Document compliance

Del Corno & Associati has experience with reformatting existing regulatory dossiers to comply with the Common Technical Document (CTD) format that is now obligatory in all EU member states, including those in the ten EU accession countries. The company can also put at your disposal resources for the implementation of the e-CTD.

About the company

Del Corno & Associati was established after long and extensive experience in regulatory affairs and market-access issues in big, multinational pharmaceutical companies. Independently owned, we’ve worked with over 25 companies, leading them to the required authorizations.

The company achieves its objectives by adhering to four criteria: quality, professionalism, excellence and speed.