Regulatory Affairs
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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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