Farmabios can proudly claim that one of its strengths lies in the area of Quality Assurance and Regulatory compliance, so much so that the company has always achieved excellent results from the inspections conducted by the Italian regulatory authorities as well as by the European authorities and the American FDA.
The company owns a GMP certificate issued by the Italian authorities.
Furthermore, since 2003, the company has also been certified in terms of the ISO 9001 and ISO 14001 systems.
The most recent Pre-Approval lnspection (or PAI) was carried out by the FDA in Sept. 2010. The result of this audit was positive, with no negative observations as regards company structure or organisational systems.
By virtue of a solid and well-structured set of Quality Systems, as well as a strong management commitment towards adhering to the regulations, all the audits carried out during the past ten years have yielded positive results and no significant areas of concern have been noted.
We have submitted numerous DMFs/CTDs worldwide and have obtained various Certificates of Suitability from the EDQM.
We are also in an excellent position to provide our customers with specialist assistance in terms of preparing the necessary data for their certification (IND, NDA and ANDA). The close collaboration between the Regulatory Affairs department and those of Quality Control, Quality Assurance and Research and Development allow to provide the Customers with the documentation required for the submission of registration applications anywhere in the world.
Our customers are always welcome to visit and inspect all of our plants.
We firmly believe that the close co-operation we enjoy with our customers, as well as the sharing of experience and sometimes different points of view enable us to challenge, maintain and improve our quality system.