BIOANALYTICAL SERVICES

Who we are

We are a bioanalytical CRO centered on analyzing large molecules (biologics, peptides and proteins). We provide services for non-clinical as well as Phase I – III, including Biosimilar,  and post-marketing clinical studies for pharma, CRO and biotech clients.

The experience in assay development / transfer and validation of immunoassays within our team of bioanalytical experts is extensive and they are always ready to discuss how to speed up your projects. 

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Scientific team

Our team of scientists averages 15+ years of post-schooling bench experience, with more than 65% comprised of PhD and Masters-level scientists that have been working with leading pharmaceutical and contract research organizations.

skills

Experience

Our experience runs deep, leveraging knowledge from +15 years of experience from pharmaceutical and biotech industry.

Adding to this is the legacy of SVAR Life science +25 years’ experience in immunoassay development, novel technologies and scientific expertise in immunological interactions.

 

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Quality Compliance

High quality standards and processes are essential when working in bioanalytical projects. We offer ISO 15189, GCP and GLP compliant services ensuring that quality requirements are met for development, validation and sample analysis.

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Project Management

Our ideal project management model provides a unique continuity, with a single point of contact and full visibility into project progress and costs at every stage. Our scientists have many years of experience in delivering high quality data, working according to applicable guidelines and regulations.

manufacture

Unique in-house
developed products

We offer proprietary off-the-shelf products, customized method development of our cell-based assays and immunoassays or utilization of our extensive portfolio of non-proprietary assays.

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Regulatory & Industry expertise

Our scientists are actively involved in industry associations (EBF, EIP, AAPS & BEPBA) and contribute perspectives at scientific events. Hereby, we are always up-to-date with the latest bioanalytical approaches and guidelines in order to help our customers effectively navigate the ever-evolving scientific and regulatory complexities of biologics development.

success

Flawless Track Record

Through the many assays we have developed, we gained unprecedented knowledge and experience in how to shorten development timelines, optimize assay performance and determine the best analytical method for your biologic.

technical-support

Analytical technologies

We have access the best analytical technologies for drug development and clinical research applications, such as cell-based assays - iLite® technology, the Simoa HD-X Analyzer™, ELISA and Meso Scale Discovery (MSD) assays. Read more...

Bioanalytical Services Solutions

Immunogenicity Testing

Detection and confirmation of ADAs and NAbs

Pharmacokinetics (PK) & Pharmacodynamics (PD)

Expertise in bioanalysis of large molecules

Toxicokinetics (TK) testing

Assessment and characterization of biologic safety of large molecules

Biomarker testing

Over 250 immunology markers at your service

Potency Testing

Determinate the functional activity of your drug molecule

Consultancy Services

Optimize your study's assay strategy and improve submission success

Let us make a difference in
your drug development project!

 

Discuss Your Project
with Our Scientists Today!

Contact us