Pharma

Tailored regulatory consulting and clinical operations support in translational medicine

Comprehensive risk management and compliance for drug and device programmes, encompassing IVDs.

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Navigating regulatory compliance in translational medicine Assisting you in decoding intricate regulations, with a spotlight on a changing regulatory landscape in USA, China and the EU.

Prioritising timeliness and patient safety Forging close collaborations with pharmaceutical firms to assure patient safety and meet project timelines.

Agile regulatory strategy development Crafting customised strategies to navigate regulatory hurdles.

Full-spectrum regulatory services Providing a wide range of solutions, from basic regulatory ethics to intricate QMS frameworks.

Join the pharmaceutical community that is already benefiting

How we can help the pharmaceutical sector

All Services

Regulatory Consulting

Delivering robust regulatory pathways for pharma.

Navigating global pharmaceutical regulations with precision.
Streamlining US submission strategies, including 510(k) and PMA strategies.
Ensuring alignment with commercialisation and business objectives for pharma projects.
Offering hands-on guidance through intricate global diagnostic regulations.

Regulatory Services

Clinical Expertise

Empowering pharma clinical development.

Overseeing each phase of IVD development and CDx studies tailored to pharma needs.
Simplifying complexities, from definition to clinical evaluation studies.
Expert guidance on clinical operations, from study site selection to ethics submissions.
Precision-driven biostatistical insights for robust data interpretation.

Clinical Services

CRO Partnership

Accelerating pharma innovations with expert clinical oversight.

Specialised CRO services focused on supporting in vitro diagnostics for pharma.
Comprehensive QMS audit services customised for pharma requirements.
Ensuring study readiness with detailed GCP assessments and robust SOP development.
Implementing risk management and usability engineering principles throughout the pharma product lifecycle.

CRO Services

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.

About ARC

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