Quality Certifications
The management of biological samples is based on high quality standards, necessary to guarantee the integrity of the researchers’ work. Through our standard operating procedures (SOP) and our highly qualified personnel, standardization and uniformity of biological samples can be ensured, in order to preserve the reproducibility conditions needed for the clinical studies and the development activities of our customers.
UNI EN ISO 9001
BioRep is certified UNI EN ISO 9001 valid for the following application field: Provision of cryopreservation services, storage and distribution of tissues, cell cultures, nucleic acids and biological fluids. Design and provision of laboratory services of cell biology and molecular biology. Design, setup and maintenance of turnkey bio-banks (Sector EA: 38 – 28).
Accreditation of Laboratory Medicine Services (SMeL)
The Lombardy Region issued the U.O. accreditation on March 19, 2019 to BioRep Laboratory Medicine Service – Specialized SMeL without sampling point – Cytogenetics and Medical Genetics Specialty, for the activity of Molecular Genetics only, with registration number 1417 of 27.03.2019 in the Regional Register of Accredited Structures. BioRep, as an accredited body, can therefore offer genetic services in service to both public and private structures, confirming itself as a reference point for laboratory services.
AIFA Authorization
Since December 2017 BioRep has obtained the AIFA aAPI – 72/2022 authorization for the storage of sterile and / or biological active substances Master Cell Bank (MCB) and Working Cell Bank (WCB).
BioRep is therefore able to provide pharmaceutical companies, biotechs and public / private research institutions with GMP storage services for biological material.
Pharmaceutical Warehouse
Since March 2021 BioRep has received from the ATS of the Metropolitan City of Milan the authorization for stock and distribution of medicines for human use in its pharmaceutical warehouse in Milan (Determination ATS Milan No. 147 of 02/03 / 2021 – Unique Distributor Depositary Code 015198 by the Ministry of Health).
BioRep is now able to stock and distribute medicines for human use to wholesalers and local structures on behalf of the A.I.C. on the basis of contracts entered into with them.
Disaster Recovery Plan
By virtue of the Ministerial authorization: N ° 0036180-23 / 12/2016-DGPRE-MDS-P, BioRep is authorized to carry out, as a third party, transport, storage and conservation of hematopoietic stem cells and transport activities, storage and preservation of reproductive cells and / or tissues, to support the emergency plan.
MOGM Plant Authorization
With Ministerial authorization: MI / IC / Imp2 / 16/002, BioRep is an Authorized plant for the use and conservation of Genetically Modified Class 2 Microorganisms according to Legislative Decree n. 206/2001.