CellCarta maintains CAP CLIA accreditation across six global laboratory sites,with ISO 15189 for clinical laboratory operations,ISO 13485 for quality management systems and companion diagnostic development,and ISO 27001 for information security.
","btn_text":"View our accreditations","btn_url":"/clinical-trial-services/regulatory-services/cap-clia-iso-accreditations/","btn_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/06/IVDR-Service-hero-373.jpg","image_alt":"","title":"IVDR ","desc":"Our regulatory team supports the full path to EU market access under the In Vitro Diagnostic Regulation. From performance evaluation planning through Annex XIII and XIV compliance,we guide CDx programs across NGS,PCR,IHC,ISH,and FISH platforms. ","btn_text":"View our IVDR services","btn_url":"/clinical-trial-services/regulatory-services/ivdr-services/","btn_target":"_self","bullets":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit.
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"}];oxy-supreme-core-solutions-header-width:default}#-supreme-cellcarta-faq-10-168{items-data:[{"faq_question":"Which regulatory frameworks and regions do your clinical trial regulatory services cover? ","faq_answer":"Our regulatory submissions services support multi-region trials across the US (FDA),European Union (IVDR),United Kingdom (IVDD),China (HGRAC),and additional markets through coordinated global filings. We align documentation with country-specific requirements to reduce rework and keep multi-country programs on timeline. "},{"faq_question":"How does CellCarta support IVDR performance evaluation for companion diagnostics?","faq_answer":"Our clinical trial regulatory services support the full IVDR performance evaluation pathway for IVD devices and companion diagnostics (CDx),including scientific validity,analytical performance,and clinical performance documentation under Annex XIII. Our team prepares the required clinical performance study plans (CPSPs) and reports (CPSRs),aligns with MDCG guidance,and supports clinical trial assay,IVD,and CDx programs across NGS,PCR,IHC,ISH,and FISH platforms.
"},{"faq_question":"What accreditations does CellCarta hold?","faq_answer":"CellCarta operates six CAP- and/or CLIA-accredited laboratories globally,with ISO 15189 for clinical laboratory operations,ISO 13485 for quality management systems and companion diagnostic development,and ISO 27001 for information security. All work is performed in compliance with GCP,GLP,and GCLP standards by qualified and trained personnel using approved SOPs."},{"faq_question":"When should we engage regulatory support during assay development? ","faq_answer":"Engage regulatory support as early as possible —ideally,during pre-submission strategy. Early engagement allows regulatory planning to run in parallel with assay development,reducing the risk of late-stage documentation gaps,protocol amendments,or submission delays. CellCarta's global regulatory affairs team integrates with assay development scientists and clinical operations from day one.
"},{"faq_question":"What types of clinical programs and therapeutic areas do you support?","faq_answer":"Our clinical trial regulatory services support strategy and submissions for oncology,immunology,rare disease,cell & gene therapy programs,and more. That includes work across biomarker assays,clinical trial assays,IVD devices,companion diagnostics (CDx),and complementary diagnostics. Our platform expertise spans flow cytometry,immunohistochemistry,molecular assays (PCR,NGS,FISH,ISH),histopathology,and multiplex immunoassays used in all phases of clinical trials (e.g.,first in human,late stage,etc.).
"}]}#-supreme-cellcarta-featured-resources-8-168{cards-data:[{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"},{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar-2.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"},{"image_url":"\/wp-content\/uploads\/2026\/05\/webinar-3.jpg","card_type":"Webinar","date":"Feb 12","reading_time":"Reading Time - 5 minutes","title":"Resources Title Goes Here","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"#"}]}#-supreme-cellcarta-overview-4-168{stats-data:[{"number":"6 ","label":"CAP & CLIA accredited labs "},{"number":"3 ","label":"ISO Certifications "},{"number":"100+","label":"HGRAC submissions supported"},{"number":"190+","label":"IVDR regulatory submissions"}]}#-supreme-cellcarta-testimonials-7-168{items-data:[{"quote":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus et magnis dis parturient montes,nascetur ridiculus mus. Donec quam felis,ultricies nec,pellentesque eu,pretium quis,sem. Nulla consequat massa quis enim. Donec pede justo,\u00a0","author_name":"John Seer","author_role":"Founder,President","author_company":"Company Name"},{"quote":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit.","author_name":"John Seer","author_role":"Founder,President","author_company":"Company Name"},{"quote":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit.","author_name":"John Seer","author_role":"Founder,President","author_company":"Company Name"}]}