GLP Regulatory-Compliant Services

Confidence through compliance, collaboration, and communication

GENEWIZ provides Good Laboratory Practice (GLP) regulatory-compliant services for FDA-level applications and submissions. High quality, reliability, and effortless collaboration with scientific and quality assurance teams, as well as commitment to excellence and consistent communication are just some of the advantages GENEWIZ offers.

Regulatory-compliant services available for FDA applications and submissions include RNA/DNA Identity and Stability Studies for: cell bank, plasmid, virus, and vaccine. Additional services include Single Nucleotide Polymorphism (SNP) testing, as well as DNA/RNA preparation for biomarker assays and validated internal controls.

GENEWIZ Commitment to High Quality & Expertise

Our mission to advance and accelerate life science research by providing reliable, cost-effective services and high-quality results remain paramount in our GLP regulatory-compliant services. As such, GENEWIZ treats all customer information, Study-related data, and intellectual property with the same degree of care and security we do for our own. Transparent communication throughout your Study with your dedicated expert Study Director reinforces our commitment to your project's successful completion.

  • GLP Services
  • Experience
  • Quality System

GLP Regulatory-Compliant Services

Final Reports & Deliverables

GENEWIZ provides both electronic and hard-bound reports for easy incorporation into regulatory submission files.

Components of customized final reports from GENEWIZ include, but are not limited to:

  • Description of all materials and procedures
  • Contig assemblies and graphic Contig overview
  • Consensus sequences
  • Details of the mutations and insertions/deletions detected
  • Raw sequence data with accompanying quality scores
  • Certificate of Analysis (COA)
  • Signed QAU Statement

Confidence in the GENEWIZ Experience

Through rigorous planning and proven methodology, GENEWIZ has gained the trust and repeat business of large, international pharmaceutical companies and smaller biotechnology companies alike. Together, we design a project-specific Study Protocol, including scope of work, SOPs, project requirements, and project deliverables. Both GENEWIZ and the project owner agree to and sign the Study Protocol prior to implementation.

The GENEWIZ experience includes:

  • Customized services
  • Technical consultation and follow-through with a dedicated Study Director
  • Validated SOPs, equipment, and facility
  • Internal and external audits
  • Competitive pricing
  • The GENEWIZ Quality System, developed in accordance with applicable FDA regulations described in Title 21, Part 58 of the Code of Federal Regulations for Good Laboratory Practice

GENEWIZ Quality System

Developed to support GENEWIZ operations, the GENEWIZ Quality System ensures quality throughout all aspects of our services. For customers, the GENEWIZ Quality System confirms strict regulatory adherence and consistency in all of your data.

GENEWIZ quality philosophy ensures that quality is built into all aspects of our services. As a trusted partner for advancing research and product development, GENEWIZ constantly strives to meet the needs and expectations of our customers.

Designed in accordance with the FDA Code of Federal Regulations (CFR), the GENEWIZ Quality System is compliant with 21CFR 58 and 21CFR 211, 600, ICH Q7A.

GENEWIZ GLP quality System

Quality by Design
  • GLP regulatory-compliant laboratories
  • Regulatory compliance and SOP education
  • Method and Assay Validation procedures
  • Custom Test Study Protocol Preparation and Reporting for your specific project requirements
  • Vendor Qualification Program ensures all vendors meet GENEWIZ Quality System standards of excellence

Quality by Assurance
  • Corrective Action/Preventative Action (CAPA) System: Identification of problem, the root cause, and continuous improvements in quality
  • Out of Specification (OOS) Investigation System: Investigation of any unexpected and/or abnormal results
  • Quality Trending System: Identification of variations or trends in data
  • Regular internal audits and management reviews

Quality by Infrastructure
  • Sample Handling and Tracking System: Controls sample check-in, processing, storage, and disposal
  • Restricted-access laboratory compliant with GLP/cGMP regulations
  • Installation, Operational, and Performance Qualification (IP/OQ/PQ) Program: Qualifies all instruments used for GLP/cGMP projects
  • On-site fire-resistant data archiving
  • Off-site data back-up storage

Request for Quote/Sample Submission

  • To request additional information, please email or call us at 1-877-436-3949.

  • Click here to request a quote via email.

We are here to help
1-877-436-3949 option 2