Your partner for Dx compliance in translational research

Start Up business agreement

Start Ups

Bespoke regulatory guidance for Start-Ups

You've been focused on finding the right idea, raising the money, hiring employees not to mention managing your cashflow. So, dealing with the red tape that is today's regulations is no easy task. ARC eases that burden by crafting regulatory strategies for market entry, tailored to your needs and realistic budget.
Cost-focused strategy Offering pathways to meet manufacturer, verification, and validation requirements without overstretching resources.
Awareness and understanding Ensuring start-ups do not bypass discussions on realistic timelines for regulatory submissions to safely bring a product to market.
Knowledge retention Assisting start-ups in maintaining essential regulatory knowledge to secure their next series of funding.
Tailored timeline strategies Crafting personalised regulatory strategies that align with your unique goals, audience, and timelines, avoiding one-size-fits-all solutions.

Join the start up community that is already benefiting

How we can help Start-Ups


Regulatory strategy for start-ups

Accelerate market entry by tailoring regulatory pathways to your unique needs.

  • Customised regulatory pathways.
  • Cost-effective compliance solutions.
  • Enhancing regulatory awareness.
  • Securing regulatory knowledge.
Medical test papers

Clinical support for start-ups

Navigate clinical development seamlessly with our expert guidance.

  • Efficient trial management solutions.
  • Comprehensive clinical oversight.
  • Effective data management.
  • Adapt to market dynamics with confidence.
Scientist in lab

CRO partnership for start-ups

Accelerate innovation with specialised clinical support.

  • In vitro diagnostics expertise.
  • Quality management audits for assured performance.
  • Protocol and data guidance.
  • Ensure safety and compliance with expert risk management.
Our Story

From Lab to Life™

Recognising the need for a more robust strategic approach to medical device consultancy, ARC Regulatory was established in 2010 by Seamus Kearney. The primary goal was to ease the journey towards regulatory compliance for companies specifically in the in vitro and companion diagnostic industries. Since it’s inception, the company has enlarged its portfolio to include regulatory quality and clinical consultancy, providing CRO services and offering digital solutions to navigate today’s regulatory landscape at home and abroad.

ARC Regulatory team
Scientist in lab
Customer Story

“At GenDx, we really appreciated the support and guidance provided by the ARC Regulatory team for our projects. Our overall experience has been very positive and the ARC team has shown to be very knowledgeable, responsive and collaborative. A great team to work with.”

Erica Kremer, Director Compliance at GenDx

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