GENEWIZ REGULATED SERVICES

GLP Compliant. CLIA Accredited. World-Class Genomic Analysis.

PRE-CLINICAL AND CLINICAL SERVICES

Depend on GENEWIZ to support your pre-clinical and clinical regulatory submissions. Our state-of-the-art US laboratory is compliant with FDA and EPA Good Laboratory Practices (GLP) and accredited by the College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA).

By joining together with Brooks Life Sciences, we now offer a complete solution to support all your clinical and regulatory needs. From sample collection and storage, through to sample processing, sequencing, analysis, and reporting. Operating with the highest-quality standards, our flexible services are customized to meet each customer’s unique specifications.

CLIA AND GLP APPLICATIONS

Therapeutic Development

Sequence confirmation support throughout pre-clinical development and clinical trials

Medical and IVD Devices Development

Orthogonal testing for validation of in vitro diagnostic accuracy to support US FDA CDRH medical device applications

Diagnostic Confirmatory Mutation Analysis

Confirmation of deleterious patient genomic alterations utilizing orthogonal platform technologies in support of diagnostics

Biomarkers and Pharmacogenomics

Confirmation of known biomarkers in pre-clinical and clinical samples

Cell Bank/Line Development

Confirmation of viral, bacterial, and human cell lines and cell banks, pre- and post- manufacturing, prior to use in therapeutics

Agricultural Product Development

GLP GMO and plant strain Identification, as per 40CFR part 160 for EPA compliance

CLIA AND GLP SERVICES

Including regulated Sanger and next generation sequencing, plasmid preparation, and pre-analytical bio-fluid processing.

SAMPLE MANAGEMENT

From sample collection and storage, through sample processing, sequencing, analysis, and reporting, Brooks Life Sciences and GENEWIZ’s regulatory services team-up to support your regulatory needs.

  • Sample Collection
    & Transport

    Brooks Life Sciences offers sample kitting and cold-chain logistics with real-time sample tracking to securely transport samples to our storage facilities.

  • Sample Storage
    & Management

    Samples are stored in Brooks Life Sciences’ CAP ISO 9001-accredited, GXP-compliant facilities with 24/7 access to our 21 CFR Part 11- compliant software.

  • Sample Retrieval
    & Pre-Processing

    GENEWIZ’s pre-analytical processing, such as extractions, PMBC isolations, and aliquoting, are performed in our CAP-accredited, GXP-compliant laboratories.

  • Sequencing, Prep,
    & Data Analysis

    Many of Sanger and next generation (NGS) sequencing services are available from GENEWIZ’s GLP-compliant, CAP /CLIA-accredited laboratory.

FEATURES & BENEFITS

  • Custom assay development and validations to support specific regulatory submissions

  • Ph.D.-level support during your entire project, including free consultations

  • Superior data quality that exceeds manufacturer’s benchmarks

  • Complementary NGS and Sanger services provide variant discovery-to-validation workflows