Consulting in the field of ict system security Echa has updated the list of suppliers of active substances or the list referred to in article 95 of Harmonized standards for the sterilization of medical devices Countdown to serialization Legacy devices Notification of production sites Medical device and uni en iso 13485:2021 Estratto dagli highlights della riunione del comitato per la valutazione dei rischi in farmacovigila Iso 14644-21 is released Manual on borderline and classification in the community regulatory framework for medical devices (s New allergens Clinical trials: questions & answers document version 1.0 (05/2023) Published the regulation 2023/707 amending the clp! Aifa: istat rates update Draft: who good manufacturing practices for excipients used in pharmaceutical 7 products Self-certification and related contribution of 7% Update on water in food supplements Q13 continuous manufacturing of drug substances and drug products Mdr - extension proposal Update on nitrosamine impurities Titanium dioxide, eu court annuls the regulation that considers it carcinogenic Publishing service gazzetta ufficiale Guidelines for the environmental labelling of packaging Hazardous substances safety data sheets: new eu regulation 2020/878 Telematic management of applications and documents issued by the gmpmed office. new provisions start Validity of authorizations as medical surgical aids for products intended for the disinfection of in Medical devices, in the official gazette the legislative decrees for the adaptation of the national Nsaids for systemic use: change request printed for use in pregnancy Reports of suspected adverse reactions Marketing of food supplements Who publishes the new draft on chromatography Ministry of health circular 4 march 2022 - ministerial indications for the placing on the market of Self-certification and relative contribution of 7% Medical device Guidance on submission of marketing authorization/extension, ma variation and renewal applications, Ema asks for checks on all the drugs on the market 59th afi symposium on 5-6-7 june at stand 83. Aifa - increase in current rates Method of submitting applications for marketing authorization, variations, renewals and asmf Lists of scientific drug informers for the year 2018 Pay-back transaction agreements 2013-2015 (20/04/2018) Brexit, ema publishes a guide to the industry in view of the uk exit from europe Pharmaceutical excipients in the label, the guidelines reviewed by ce Update: guideline on the excipients warnings to be included in the printed of homeopathic medicines Lists of medical representatives medicines for the year 2016 Guideline on the excipients warnings to be included in the printed of homeopathic medicines (12/12/2 Aifa incoming single text changes "non-essential" Medical devices, from spring 2017 they change the rules

REGULATORY AFFAIRS

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:

  • Human and Veterinary Medicinal Use;
  • Homeopathic medicines Human and Veterinary Use;
  • Medical devices;
  • Dietary, nutraceutical and herbal;
  • Medical and surgical instruments and biocides
  • Cosmetics
  • Ecolabel - Certification of Environmental Quality
Elaborating the technical documentation, including SMF, VMP, CTD, POS, IQ, OQ, PQ and all issues concerning the security, making specific Management Systems Quality and following the entire bureaucratic process at the Ministry of Health and AIFA Departments responsible for issue the requisite authorizations. Run accurate pre-inspection audit cGxP-GAMP-FDA, feasibility studies & agrave; and specific training activities. Significant is the experience gained in Parallel Import of Drugs. The professionalism and the results obtained have allowed BIO CHEM to assume the prosecution of many leading companies in the industry.

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QUALITY CONTROL IN THE PHARMACOLOGICAL SECTOR

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REGULATORY BUSINESS AND QUALITY CONTROL

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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REGULATIONS

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LOCATIONS

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SURVEY

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