We provide professional regulatory affairs assistance throughout all phases of development.
Methods of support
- Regulatory revision of development plans. RPN’s team of qualified consultants can assist you towards a smooth and timely pathway of regulatory approval. We will also assess your scientific data to identify any deficiencies, as well as help you plan future studies
- Scientific advice request. We provide assistance throughout the preparation of supporting documentation and presentation of the questions and company position, for both national and centralised advice. We can also take care of communications/meeting with the Authorities, even acting on your behalf
- Orphan drug designation applications. RPN supports you for the preparation of orphan drug designation applications in EU and USA. On the basis of the data provided by the client, we prepare the application including details on the target condition, the proposed indication and the medical plausibility, a justification of the life-threatening or debilitating nature of the condition, information on the prevalence of the condition and on the existence of other methods of diagnosis, prevention or treatment. In addition, we take care of translations of the active substance and proposed indication in all EU languages
- Paediatric investigation plan (PIP) applications. RPN can advise on the approach for PIP, deferral and/or waiver applications, according to the Paediatric Regulation (EC) No.1901/2006 and 1902/2006. We support for the preparation of the relevant documentation, submission and follow-up of your Company’s PIP application. We can also take care of communications/meeting with the Paediatric Committee (PDCO), even acting on your behalf
- Clinical trial applications. RPN has a wide experience in the preparation and submission of clinical trial applications to the Competent Authorities and to the Ethics Committees, so as subsequent amendments and check progression of the applications until approval. We assist sponsors for mandatory data entry into the Italian Agency database for clinical trials ("Osservatorio Nazionale sulla sperimentazione clinica dei medicinali")