Regulatory Affairs

Hyperphar offers full Regulatory Affairs services, including:

• Regulatory drug development strategy
• EUDRA-CT number request
• CTA (or equivalent) preparation
• CAs, single opinion and Ethics Committee applications
• Notification to the Italian Registry of Clinical Trials (OsSC)
• Regulatory consultancy and support
• Pre-Clinical Expert Report writing
• Clinical Expert Report writing
• Integrated Summary of Safety Reports
• Integrated Summary of Efficacy Reports
• Review and assembly of registration dossiers for MRP, centralized, decentralized and national applications
• e-CTD applications
• Performance of "Users' testing"
• Filing and follow-up of regulatory applications
• Price negotiation

Hyperphar can provide you with medical and regulatory consultancy services to help plan your development process. Hyperphar is connected with partner Regulatory Affairs companies throughout Western and Eastern Europe with experience in every aspect of registration procedures in the European territory.

Should your project require specialist knowledge, Hyperphar can draw on the resources from any of its companies to ensure that you are provided with the expertise to get your project completed and/or product approved as quickly as possible. This is particularly useful in exercises such as accessing information on products in several countries, translation of product literature, and advice and assistance on international projects such as mutual recognition procedures and centralised procedures.