Supporting its international clients in the bureaucratic management of radiopharmaceutical production, BeForPharma has developed considerable specialist expertise in the regulatory field.
The team is therefore able to analyze the needs of the client, the initial situation, the regulations that apply and the guidelines to follow (laws, decrees and community directives and regulations), before developing an exhaustive and personalized analysis of how the authorization process should be managed.
BeForPharma not only analyzes the legislation and guidelines, but also produces a dossier of documentation, and presents authorization requests on behalf of the client.
In particular, the company has specific experience in dossiers for:
• placing on the market (Marketing Authorization Application, MAA);
• activities that follow the granting of the marketing authorization;
• in some cases, requests for variation to the marketing authorization.