The role of the regulatory consultant in the pharmaceutical sector has become more and more central in recent years: the high level of the regulations introduced in Europe has in fact made necessary the presence of a steady reference point in an ever-changing normative landscape.
Even in the new health emergency, determined by the COVID-19 pandemic, the role of the pharmaceutical consultant remains essential to face the several unexpected needs that have arisen.
One of the main activities of pharmaceutical consultancy is the daily consultation of the authorities’ websites to learn in real time about any new procedure introduced by the competent authorities (AIFA, Ministry of Health, ISS etc.). Those introduced in these days of emergency were many and at all levels: from the changes in the submission of applications and documents to the novelties provided for many procedures, from the suspension of the document delivery to the temporary norms to ensure that services are carried out in safety. In these cases, the consultant’s task is a prompt update of the Italian or foreign client, so that this can continue to comply with the regulations in force, even when changed in virtue of exceptional circumstances.
But a good pharmaceutical consultancy can also support the client in the identification of new opportunities. This is the case, for instance, of the parallel importation of drugs, especially antivirals, and in general all those used in the treatment of COVID-19 and in supporting therapies. Consultants can, among other things, help their clients in reporting any drug shortage, especially those required and subject to a specific monitoring by the authorities in this delicate moment.
The registration of kits for serological tests, currently very much requested, is also a field where companies can avail themselves of a consultant with expertise in in vitro diagnostics, whereas in the case of disinfectant products, the required regulatory consultancy will fall into the field of application of biocides and PMCs (presidi medico chirurgici, medical surgical aids).
A special case is the issue on protective masks, where the intervention of a pharmaceutical consultant can be even crucial. Many companies usually operating in sectors other than personal protective equipment (PPE) have in fact started to manufacture protective masks- – either to give their contribution to the fight against the epidemic or to diversify their production. These companies know very little about regulatory affairs in the field of health, and the possibility to glean from the resources and competence offered by pharmaceutical consultancy can be the only way for them to get quickly all licences required.
The role of the regulatory consultant is then essential, in times of usual business as well in extraordinary circumstances, to ensure companies the operative continuity they need.
Written by: Maria Pia Felici