From early product development, our team of consultants can guide you to a regulatory pathway that will lead directly to a smooth and timely regulatory approval. Your scientific data can be assessed to identify any deficiencies and plan future studies.

Scientific advice is encouraged and with the availability of both national and centralised advice, the best tactical route at a given stage of development needs to be decided. We support our clients for the preparation of the supporting documentation and presentation of the questions and company position.
We can help prepare a scientific advice request and either assist in communications with the Authorities or act on your behalf.

We support 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 for translations of the active substance and proposed indication in all EU languages.

According to Article 7 of the Paediatric Regulation, a marketing authorisation application (MAA) for a new medicinal product must include the results of studies performed in compliance with an agreed paediatric investigation plan (PIP) and/or a waiver and/or a deferral, which combined, shall cover all subsets of the paediatric population. Therefore, prior to submitting a MAA for a new medicinal product in the EU, it is now mandatory to submit an application for a PIP and/or a request for a deferral and/or waiver, and to obtain agreement from the European Medicines Agency (EMA). We can advise on the requirement for a PIP.
We support for the preparation, submission and follow-up of the PIP for your company.

The European Clinical Trials Directive requires that before a clinical trial can commence in a Member State of the EU, a request for authorisation to conduct a clinical trial must be submitted to the competent authority of the Member State(s) concerned and approval must be obtained from the relevant Ethics Committee(s). Differences exist in the way the Directive was transposed into national legislation of individual Member States so that the requirements are not completely harmonised. We have a wide experience in the preparation and submission of clinical trial applications and subsequent amendments to the competent authorities and to the Ethics Committees 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”).