BIO CHEM carries out its consulting activities in the chemical-pharmaceutical and health sector, specializes in Regulatory Affairs and provides companies, in Italy and Europe, a full service, with particular regard the performance of each type of practice at the Ministry Health and Medicines Agency including the activation and reactivation of production workshops. It provides, where necessary, comprehensive civil and criminal legal aid. In compliance with the regulations, for formulations studies and productions are made of:
Quality control, in the pharmaceutical field, is an aspect that cannot be ignored, especially as the regulations are increasingly stringent today. Regulatory Affairs management is the professional activity that must know and work perfectly in compliance with the legislation that regulates the pharmaceutical, cosmetic sector and all activities subject to the authorization of AIFA and the Ministry of Health, ensuring that requests for authorization for the marketing of an allopathic or homeopathic drug, a medical device, a medical surgical device and / or biocide, a food supplement, a cosmetic, are correct. In addition to quality understood as compliance with company processes in drug production, regulatory compliance is also of no secondary importance, which is the subject that Specialist Regulatory Affairs deals with in particular. This is a specific professional figure who combines particularly in-depth expertise in legal and regulatory matters with pharmacological ones.
If until a few years ago they were less important aspects in the context of pharmaceutical production, today pharmacovigilance, cosmetovigilance, phytovigilance, health surveillance for MDs and quality control, are increasingly closely linked with regulations, making in fact, it is essential to rely on external agencies specialized in the sector. To comply with the regulations, in fact, it is necessary to put in place an organizational and management system that involves all the production and control steps of the drug, involving all company departments. Entrusting this corporate reorganization to external specialists often proves to be particularly useful, as it allows to analyze the critical issues more objectively and to improve company productivity.The Head of Regulatory Affairs, therefore, acts as an intermediary between the requests of the authorities and the needs expressed by all the functional areas of the company. When he submits an application for the placing on the market of a product, he must prepare, in support of the authorization request, specific documentation, divided into three sections:
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