Regulatory expertise

We provide submission-ready microbiome data packages through our GxP compliant services to be part of your trial master file for regulatory submissions.

Clinical Microbiomics is one of the few microbiome service providers offering full support for regulatory submissions. We support your regulated studies with standardized procedures, validated workflows, and alignment with authority regulations 

Our team has experience with scientific, quality, and regulatory oversight for regulated studiesensuring proper documentation based on well-founded scientific principles and adhering to regulatory requirements of relevant authorities such as EFSA, EMA and FDA. When you work with us, we assign a dedicated team that includes a regulatory affairs and quality assurance expert in addition to the science lead, project manager, and team members responsible for operations and partnerships. Together we decide on a suitable study design and analysis, always keeping in mind the long-term goals and benefits of introducing microbiome endpoints into your product development. 

We deliver high quality data, then assist you in interpreting the data and linking it to clinical outcomes, ultimately helping you reach your regulatory submission goals. As a specialist microbiome company, we have developed scrutinized scientific argumentations for areas in which regulatory frameworks are not concrete, and where the methods for microbiome analysis differ compared to more established methods such as chromatography. We not only stay up to date on major regulatory changes that occur, but have also invested in developing and implementing internal processes at Clinical Microbiomics to achieve GxP compliance and adhere to authority regulations. We offer continuous quality compliance and regulatory support throughout your regulated studies, and regulatory strategic support when developing the analysis plan detailing the long-term goals for supporting your product profile and differentiation  

Book a meeting with our in-house regulatory and quality assurance experts to walk through our regulatory compliance processes and learn more about how these can benefit your clinical development programs. 

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