Your partner for Dx compliance in translational research

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Leading Regulatory Strategy Solutions for Diagnostics

Partnering with you through intricate global diagnostic regulations.

At ARC Regulatory our primary goal is to deliver platinum-standard solutions for companies in the in vitro diagnostic and companion diagnostic medical device industry. By integrating our services and expertise at various stages throughout the product development lifecycle, we guide and support companies through the myriad global regulations to ensure that every project’s commercial and compliance objectives are achieved.

James Lappin

Our consultants have extensive knowledge and experience of regulatory requirements for in vitro diagnostic medical devices, gained from working on a wide range of industry projects 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.
Scientist writing on whiteboard

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.
Consultant and laptop

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)
Scientist writing
DNA String

Get in touch with our expert team today