Quality Certifications

The management of biological samples is based on high quality standards, which are essential to safeguard the integrity of researchers’ work. Through our Standard Operating Procedures (SOPs) and highly qualified personnel, we ensure the standardization and consistency of biological samples, preserving as far as possible the reproducibility conditions required for clinical studies and our clients’ development activities.

BioRep is UNI EN ISO 9001 certified for the following scope: Provision of cryopreservation, storage, and distribution services for tissues, cell cultures, nucleic acids, and biological fluids. Design and provision of cell biology and molecular biology laboratory services. Design, implementation, and maintenance of turnkey biobanks (EA Sector: 38 – 28).

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On March 19, 2019, the Lombardy Region granted BioRep accreditation for its Laboratory Medicine Service Unit – Specialized SMeL without a sample collection point – Cytogenetics and Medical Genetics specialty, limited to Molecular Genetics activities, with registration no. 1417 dated March 27, 2019 in the Regional Register of Accredited Healthcare Facilities.

As an accredited organization, BioRep can therefore provide outsourced genetic testing services to both public and private healthcare facilities, further strengthening its role as a reference point for laboratory services.

Since December 2017, BioRep has held AIFA aAPI authorization for the storage of sterile and/or biologically derived active substances, including Master Cell Banks (MCBs) and Working Cell Banks (WCBs).

BioRep is therefore able to provide pharmaceutical and biotech companies, as well as public and private research institutions, with GMP-compliant storage services for biological material.

Since March 2021, BioRep has been authorized by the Health Protection Agency (ATS) of the Metropolitan City of Milan for the storage and subsequent distribution of medicinal products for human use at its pharmaceutical warehouse in Milan (ATS Milan Determination No. 147 of March 2, 2021 – Unique Depositary Distributor Code 015198 issued by the Italian Ministry of Health).

BioRep is therefore able to store and distribute medicinal products for human use to wholesalers and local healthcare facilities on behalf of Marketing Authorization Holders (MAHs), under agreements entered into with them.

Under Ministerial Authorization No. 0036180-23/12/2016-DGPRE-MDS-P, BioRep is authorized, as a third party, to carry out the transport, storage, and preservation of hematopoietic stem cells, as well as the transport, storage, and preservation of reproductive cells and/or tissues, as support for emergency and disaster recovery plans.