Leading Regulatory Strategy Solutions for Diagnostics
Partnering with you to untangle intricate global diagnostic regulations.
At ARC Regulatory our primary goal is to deliver platinum-standard in vitro diagnostics assay compliance solutions for companies in the precision medicine sector. By integrating our services and expertise at various stages throughout the clinical development lifecycle, we guide and support companies through the myriad global regulations to ensure that every trial’s commercial and compliance objectives are achieved.
Our consultants have extensive knowledge and experience of regulatory requirements for in vitro diagnostic medical devices being implemented in to complex precision medicine studies, gained from working on a wide range of high profile trials and interfacing directly with global regulatory authorities.
Regulatory Strategy
Navigating the product lifecycle demands a detailed regulatory strategy.
ARC develops regulatory strategies that cover the entire product lifecycle, from feasibility to obsolescence, ensuring alignment with your commercialisation and business objectives.
Partner with ARC Regulatory for:
Including 513(g) requests for information, Q-submissions, alignment on analytical & clinical validation strategy, protocol design, 510(k), de Novo and PMA strategies.
Briefing document development and consultation planning for Japan, in collaboration with your MAH.
Review of existing processes and strategies against regulatory requirements. ARC support your product teams in closing gaps and implementing your regulatory strategy.
From feasibility to market launch, ensuring alignment with your commercialisation strategy
Our understanding of the product lifecycle and global regulations equips us to offer you hands-on guidance and actionable solutions, ensuring your product strategies are both compliant and market ready.
Regulatory Submissions
Managing regulatory submissions is critical in the regulatory process.
We collaborate with your product teams throughout the development lifecycle and the implementation of your submission strategy, to ensure regulatory requirements are understood and documentation is submissions ready.
Partner with ARC Regulatory for:
Collaborating with your teams to understand your objectives and integrate regulatory requirements early in the development pipeline.
ARC supports the development of a submission package in the appropriate format for Regulatory Authorities, carries out the submission directly or assists with your established submission process.
Liaise with regulatory authorities on your behalf or in collaboration with your product development teams to address any information requests and keep the review clock on track.
Efficient oversight for end-to-end submission management
Our submission experience includes:
- • US FDA: 513(g), Q-submissions including Pre-submissions and Study Risk Determinations, IDE application, 510(k) and PMA documentation
- • EU: Annex XIV performance study application and notification, CE Technical Documentation
- • Ethics: Local ethics/IRB submissions for clinical investigations and performance studies globally
- • Rest of World (ROW) ARC’s team have experience in global submissions across a number of territories such as Australia, Canada, Japan, South America, China. Contact us for more information.
Focused Medical Writing for IVD and CDx
Our team of experienced medical writers can develop a range of documentation required throughout the product life cycle and review your existing documentation supporting device clinical evidence or submission:
Partner with ARC Regulatory for
Performance Evaluation Plans (PEP), documenting the State of the Art (SOTA), Scientific Validity Reports (SVR) and Performance Evaluation Reports (PER)
Write, review and submit documentation knowing it’s right the first time
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