Navigate regulatory complexity with support in assay development, medical management in clinical trials, study documentation, and submission readiness.
CellCarta's regulatory submissions services support teams through every phase, from pre-submission strategy and design controls to performance evaluation, regulatory submissions, and post-approval compliance.
Our regulatory team works alongside development scientists, clinical operations, and business development to build integrated strategies tailored to your program's timeline, geography, and modality.
Whether your assay is headed toward US FDA submission, EU IVDR compliance, China HGRAC filing, or global multi-country coordination, we align the regulatory path with your clinical and commercial goals from day one.
Regulatory requirements for clinical trial assays are becoming more complex through expanding documentation needs, country-specific requirements, and tighter timelines.
CellCarta helps you take a more structured, proactive approach to regulatory strategy. By combining assay knowledge, documentation support, and global regulatory affairs expertise, our regulatory team reduces uncertainty and keeps studies moving.
With CellCarta, you gain:
Global regulatory affairs services that keep your data, documentation, and processes aligned with regulatory expectations.
Our quality management system is embedded across every stage of your study, from planning through reporting and archiving. All work is performed in compliance with GCP, GLP, and GCLP standards by qualified personnel using approved SOPs and client-specific procedures.
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.
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.
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.
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.
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.).
