Pharmaceutical legislation


LNAge stands out for a consolidated experience and an in-depth knowledge of the pharmaceutical legislation in force in Italy and, more generally, in all the regulatory aspects related to the pharmaceutical sector, biotechnology and labor law in the health and clinical field.
Our company is, therefore, able to offer its sponsors and other types of customers and partners legal advice and assistance in regulatory activities complete and punctual for all the activities and services it normally carries out: from the development, production, up to the marketing and promotion of medical devices, food supplements and functional cosmetics.


Pharmaceutical legislation

The regulator

In its activity of CRO LNAge has always paid particular attention and constant in-depth analysis to those aspects of pharmaceutical legislation that govern the contracts between contract research organizations and with other partners, such as pharmaceutical sponsors and university and private research centers.
In its many years of professional activity LNAge has also developed a secure know-how on many aspects of the law of the health and clinical sector that have become of crucial importance, among them: the legislation on Privacy and on the processing of personal data (Legislative Decree 196/2003 and subsequent amendments and additions) and the sensitive data of patients processed during the different research protocols.
Added to this are complementary services that, although not part of the legal consultancy activity, are carried out in strict compliance with current sector legislation and quality standards for which LNAge has obtained specific certification; among them we remember the document management through digitization and electronic archiving and consultancy on commercial aspects such as distribution policies.
As part of the activity carried out in training in the pharmaceutical sector, we point out, finally, that LNAge regularly designs and delivers training interventions, seminars and conferences on specific aspects of pharmaceutical legislation, of particular interest to sponsors, partners and private customers.


Pharmaceutical legislation

The clinical trial

According to the provisions of current pharmaceutical legislation, the legal and regulatory advice provided by the CRO and, in particular, by the monitor, becomes of fundamental importance in the context of the clinical trial. The CRO, and with it the monitor, stands, in fact, as an indispensable interface between the sponsor of a clinical trial and the hospitals where the clinical trial takes place.

The monitor in charge of legal advice and regulatory turns, on this occasion, to the Ethics Committee of the hospital structure to propose the clinical trial activity of a specific medical device or a specific therapeutic protocol and to obtain the necessary approval.

To this end, after understanding what are the documents to be submitted to the Ethics Committee, for the evaluation of the experimentation activity, the monitor in charge of legal advice takes care of collecting and, if necessary, drawing up these same materials, in particular: the dossiers, the study protocol, the synopsis, the curriculum and other documents relating to the investigators, the technical data sheet of the drug of which you want to start the trial and the letter to the attending physician.
In the drafting of the protocol of the clinical study, an activity of particular importance from the regulatory point of view, and of the attached documentation, the importance of the paper or electronic CRF should be emphasized: the Case Report Form (the card, however anonymous, with which the data of interest for the clinical study are collected) varies, in fact, from protocol to protocol and the CRF used in a specific clinical trial must obtain the prior approval of the Ethics Committee of the structure that hosts the experimentation activity.
Among the activities that have as their object the pharmaceutical legislation there is also the verification of the specific regional rules on clinical and health research of which the monitor will have to take into account before and during the trial at a given hospital, public or private.


Legal advice on Italian legislation

The experience gained by LNAge in Italian pharmaceutical legislation and in the most recent regulatory provisions introduced in our system for its harmonization with the Community regulations on clinical and health research, make our company a particularly reliable partner for pharmaceutical companies and CROs from foreign countries and, above all, of non-European countries, which intend to carry out experimentation and marketing of a medical device in our country.

To carry out their research and development activities and to place a new drug on the Italian market, these companies need, in fact, a partner who knows in depth every aspect of the specific legislation in force in Italy, in the pharmaceutical and biotechnology sectors.