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We are proud to present the Biomex Network. Within the network, we are able to provide all necessary products and services that are needed to develop, validate, register and produce an IvD.
Biomex, founded in 1989, has over 25 years of experience in the delivery of human-based raw materials such as disease state plasma and patient samples. Over 95% of all delivered human materials are sourced in our donor centers in Heidelberg, Munich and Cameroon. In addition to the delivery of biological and clinical materials, Biomex also offers a spectrum of services, for example, assay validation or CE marking.
Medical Research Networx (MRN), our American affiliate, has an extensive network of Principal Investigators who perform biological sample collections of a broad range of patient popula- tions, including but not limited to infectious diseases, oncological, endocrinology, chronic diseases and normal. MRN’s network is capable of recruiting PI’s and providing administrative and regulatory assistance to develop protocol approved, client directed collections of any clinical population that are required from clients.
Biomex US is specialized in the production and delivery of an entire range of human serum from normal to flash frozen to AB male serum.
DiaMex, develops and produces plasma based manufacturer-independent multi-analyte serological controls. Aside from its own Optitrol portfolio, DiaMex also offers a wide range of tailor made serological controls.
ESfEQA, is an worldwide EQA program provider. Through the Biomex network, ESfEQA has the ability to supply an EQA scheme with samples that are most similar to patient samples.
• Bulk plasma for production
• Residual patient samples
• Prospective sample collections
• Panels for R&D and QC
• Reagents for ELISA
We are proud to have a world-wide reach and to be the only company that covers all aspects of products and services needed for the R&D, QC and production of serological and NAT tests.
Within Basel neighbourhood and at the very heart of Europe (the triple border of France, Germany and Switzerland), Firalis is a pioneering biotechnology company, active in discovery, development and qualification of biomarkers (BM).
1) BIOMARKER PRODUCTS
Firalis develops BM-based diagnostic, prognostic and theranostic tools:
● RUO Kits (Research-Use-Only), based on validated innovative biomarkers
● IVD Tools (In Vitro Diagnostic), based on a combination of clinically qualified biomarkers
2) BIOMARKER R&D
● Development of proprietary BMs
- Cardiovascular, Inflammatory, Autoimmune and Neurology
● Drug Safety & Drug Efficacy
● Patient Stratification
● Personalized Medicine
3) BIOMARKER-RELATED CRO SERVICES
BM Discovery for laboratories, biotechs and pharmaceutical industry:
- Proteomics: Soluble biomarker measurements with several immunoassays technologies (ELISA, multiplex and high sensitivity platforms such as Luminex® BioPlex 200™, Meso Scale Discovery®, Singulex Erenna®, Protein Simple Ella™, Olink and Siemens Dimension® EXL™ 200)
- Genomics/Transcriptomics: Targeted sequencing of miRNA and mRNA (HTG EdgeSeq), lncRNA screening via Firalis proprietary platform, Next-Generation Sequencing (NGS) services (RNA-Seq, whole genome and exome sequencing, etc.) and qPCR/microfluidic qPCR (Gene Expression, SNP, CNV, etc.)
- Flow Cytometry: Immunophenotyping of preclinical and clinical samples, monitoring of pharmacodynamics on target cells in response to treatment and biomarker discovery
- Assay development and validation on various platforms, development of critical reagents (antibodies and proteins)
- Biobanking and sample repository services supported by LIMS
- Data analysis using multi-parametric statistics and development of predictive models
- Support of regulatory activities related to biomarker qualification with Health Authorities (FDA/EMA)
- Quality environment (ISO 9001, ISO 13485 (GMP), ISO 17025 (GLP/GCLP))
For more information please visit our website.
- Your international Experts for Laboratory Testing and Regulatory Services -
Your benefit at a glance:
All OECD - Laboratory Tests, Regulatory- and Toxicological Expertise – Everything from a single source
- More than 80 cooperation laboratories
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- Regulatory and Toxicological Expertise
- Optimal Test Strategy Development
- Study Monitoring
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Benefit from our know-how, our experienced collaborators and an international well established network of partners: thoroughly selected experts, toxicologists and more than 80 accredited testing laboratories and service providers with an over 25 years' track record in the industry.
We, INVITRO-CONNECT GmbH, are a team of professionals in the areas of study coordination, project management, study monitoring, quality assurance and standardization and optimization of project processes. We therefore can take care of a large number of test substances and products in collaboration with our partners.
We provide a full range service from the development of an excellent test strategy, over the project and laboratory coordination to study monitoring, toxicological expertise and including the registration dossier - and this worldwide!
Expert Services offered:
•REACH Testing Services
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•Medical Device Services
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Tests and Studies offered:
Phys-Chem-, in vitro-, Mutagenicity-, Toxicological-, Inhalation-, Environmental Tox-, E-Fate-Studies and Microbiological Testing etc.
Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.
Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.
Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).
Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at email@example.com.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries, operating more than 800 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
Eurofins is one of the fastest growing listed European companies. Since its IPO on the French stock exchange in 1997, Eurofins’ sales have increased by 35% each year (in compound average) to over EUR 4.5 billion in 2019.