International Services
Zilgene assists international laboratories with acquisition of CLIA license that enables the processing of samples originating from the USA. Our extensive experience with licensure and accreditation benefits international laboratories by facilitating the process and allowing favorable results with minimum disruption to the normal workflow. We understand how difficult it is to navigate the way to CLIA certification and CAP accreditation. Therefore, our goal is to take that burden and responsibility away from you to allow your laboratory to continue providing its usual services without distractions or interruptions.
Zilgene can also provide guidance through the ISO 15189 certification. We work with research institutions, pharmaceutical industry, and CROs to establish the CLIA and CAP standards throughout their national and international network of providers, use good laboratory practices, and be able to conduct multisite studies with the highest quality standards.
Our goal is to build up on the already existing systems and accomplish the certification and accreditation in the fastest and least invasive way. We take pride in the quality of our work and rely on satisfied customers as a gauge to our success.
International Services
International Services
International Services
CLIA Licensure
Laboratory personnel qualification to meet CLIA standards for your laboratory’s level of complexity
Competency assessments
CAP Accreditation
QC records and IQCP
QA Plan
Monthly QA meetings with a custom report including relevant quality indicators
Establish Standard Laboratory SOP’s
Assistance with necessary forms and templates
Assistance with initial assay validation and verification
Initial onsite audit, recurring visits as needed, pre-inspection audit.
Presence in announced inspections and availability to assist with unannounced inspections
Post-inspection responses and corrective action plan.
Provision of Laboratory director and Interim Laboratory Director as needed.