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.


  • Medical Device

    From 1 December 2021, the national medical device database, established pursuant to Article 13 of Le.... Continues...
  • Guidance on submission of Marketing Authorization/Extension, MA Variation and Renewal applications,

    Guidance on submission of Marketing Authorization/Extension, MA Variation and Renewal applications, .... Continues...
  • EMA asks for checks on all the drugs on the market

    The European Medicines Agency asks for precautionary checks on all products to exclude the presence .... Continues...
  • 59th AFI Symposium on 5-6-7 June at Stand 83.

    The 59th AFI Symposium is approaching Bio Chem Srl will be present at the 59th AFI Symposium on 5-6.... Continues...
  • AIFA - Increase in current rates

    Companies are advised that, from 1 January 2019, the tariffs contained in annex 1 of the D.M. 6 Dece.... Continues...
  • Method of submitting applications for marketing authorization, variations, renewals and ASMF

    Please note that AIFA adheres to the eSmissionMap of the Roadmap from the HMA and that, in accordanc.... Continues...
  • Lists of scientific drug informers for the year 2018

    Article. 122 paragraph 1 of Legislative Decree 24 April 2006, n.219 (issued in implementation of Dir.... Continues...
  • Pay-Back Transaction Agreements 2013-2015 (20/04/2018)

    In order to allow this Agency to comply with the requirements of the 2018 Stability Law, in the term.... Continues...
  • Brexit, Ema publishes a guide to the industry in view of the UK exit from Europe

    EMA and the European Commission have published a document in support of the pharmaceutical industrie.... Continues...
  • Pharmaceutical excipients in the label, the guidelines reviewed by Ce

    The European Commission has published a review, open to comments until May 22 on the list of ingredi.... Continues...
  • Update: Guideline on the excipients warnings to be included in the printed of homeopathic medicines

    It is announced that during the meeting of 19 January 2017, the Commission Scientific Technician (CT.... Continues...
  • Lists of medical representatives Medicines for the year 2016

    Communication Italian Drug Agency With effect from 2017 it will be implemented a new system that wi.... Continues...
  • Guideline on the excipients warnings to be included in the printed of homeopathic medicines (12/12/2

    Guideline on the excipients warnings to be included in the printed (label and package leaflet) of ho.... Continues...
  • AIFA incoming single text changes "non-essential"

    Identify and categorize general cases and clarify some cases considered "borderline", to define the .... Continues...
  • Medical devices, from spring 2017 they change the rules

    From syringes to contact lenses, even aesthetic ones; from blood products to reagents for diagnosis;.... Continues...


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