BIOSERV
Independent, owner-managed analytical laboratory (Rostock, Germany) operating under DAkkS accreditation and GLP frameworks. Services include accredited microbiological, molecular and chemical testing for food, feed, water and medical devices; ISO 10993 biocompatibility testing and toxicological risk assessment; GLP non-clinical studies including histopathology; hygiene and environmental monitoring; standardised on-site sampling and sample logistics; and laboratory digitisation (LIMS). The laboratory serves regional, national and international customers and operates across multiple sites.
Industries
Nr. of Employees
small (1-50)
BIOSERV
Services
Microbiological, chemical and physical testing of food and feed matrices, evaluation, labelling inspection and consultancy; sample logistics and reporting.
Biocompatibility testing aligned with the ISO 10993 series, chemical characterisation, risk management support (ISO 14971), sterility and usability testing, clinical evaluation support and conformity assessment assistance.
Surface, air and water microbiological testing, HVAC and cleanroom inspections, bio-indicator evaluation and process validation services for hygiene control.
Accredited microbiological and chemical testing of drinking and process waters for compliance with national drinking water regulations, including standardised sampling, result reporting and authority notification where required.
GLP-conformant in vitro and in vivo testing and documentation for safety assessment and regulatory submissions, including histopathology and long-term implant compatibility studies.
Seminars and workshops on food safety (HACCP, microbiology), ISO/regulatory guidance and consultancy on quality management and legal requirements.
Microbiological, chemical and physical testing of food and feed matrices, evaluation, labelling inspection and consultancy; sample logistics and reporting.
Biocompatibility testing aligned with the ISO 10993 series, chemical characterisation, risk management support (ISO 14971), sterility and usability testing, clinical evaluation support and conformity assessment assistance.
Surface, air and water microbiological testing, HVAC and cleanroom inspections, bio-indicator evaluation and process validation services for hygiene control.
Accredited microbiological and chemical testing of drinking and process waters for compliance with national drinking water regulations, including standardised sampling, result reporting and authority notification where required.
GLP-conformant in vitro and in vivo testing and documentation for safety assessment and regulatory submissions, including histopathology and long-term implant compatibility studies.
Seminars and workshops on food safety (HACCP, microbiology), ISO/regulatory guidance and consultancy on quality management and legal requirements.
Expertise Areas
- ISO 10993 biocompatibility testing and toxicological risk assessment
- GLP-compliant non-clinical study conduct
- Microbiological drinking-water testing and regulatory compliance
- Food and feed analytical testing
Key Technologies
- Microbiological culture methods
- Polymerase Chain Reaction (PCR)
- ELISA and immunoassays
- Gas Chromatography (GC)
News & Updates
Commentary and service positioning following a January 2025 FDA warning letter to a manufacturer, emphasising the need for validated processes and robust quality controls in pharmaceutical/manufacturing.
Summary of changes in the ISO/FDIS 10993-1:2025 draft, implications for biological evaluation planning, material characterisation and testing requirements.
Notice that the FDA draft guidance on design and reporting of animal studies for 510(k) submissions mirrors current laboratory review practices for preclinical testing.
Recipient of regional funding (Zuwendungsbescheid) on 11 April 2024 to research preclinical procedures for bio- and hemocompatibility testing of coated stents.
Commentary and service positioning following a January 2025 FDA warning letter to a manufacturer, emphasising the need for validated processes and robust quality controls in pharmaceutical/manufacturing.
Summary of changes in the ISO/FDIS 10993-1:2025 draft, implications for biological evaluation planning, material characterisation and testing requirements.
Notice that the FDA draft guidance on design and reporting of animal studies for 510(k) submissions mirrors current laboratory review practices for preclinical testing.
Recipient of regional funding (Zuwendungsbescheid) on 11 April 2024 to research preclinical procedures for bio- and hemocompatibility testing of coated stents.