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
- 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.
AIFA - Increase in current ratesCompanies 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 ASMFPlease 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 2018Article. 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 EuropeEMA and the European Commission have published a document in support of the pharmaceutical industrie.... Continues...
Pharmaceutical excipients in the label, the guidelines reviewed by CeThe 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 medicinesIt is announced that during the meeting of 19 January 2017, the Commission Scientific Technician (CT.... Continues...
Lists of medical representatives Medicines for the year 2016Communication 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 (12/12/2Guideline 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 rulesFrom syringes to contact lenses, even aesthetic ones; from blood products to reagents for diagnosis;.... Continues...
Login to our private area to have access to content reserved for members.
Our company offers courses from different content for different sectors.
Please login to the private area to download the pdf file of the regulations.
View all Bio Chem Srl headquarters in Naples, Rome, Milan and London.
Enter e-mail address to subscribe and receive information about our initiatives.Newsletter
The area dedicated to external links you will find all the links to our partners.Link Partner
From the following link will download the business service evaluation questionnaire regulators.Survey