Your Full-Service
Global Regulatory, Compliance & Quality Consultancy

Specialty spanning the entire GxP product lifecycle.


Define the optimal regulatory pathway.

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Streamline submissions & time to approval.

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with confidence.

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Uphold in-market product quality & integrity.

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Pharmaceutical, biologics, medical device, and diagnostics manufacturers of all sizes can tap the value of our proven platform.

The Most Specialists

Under One Roof

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Pre- and Post-Approval

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Global Scope
& Reach

US, Europe, Asia, ROW

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Fast & Flexible

With Tailored Delivery

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Our Full-Service Approach for


We don’t just advise; we also work hands-on to put your regulatory, compliance, or quality strategies into action.

Speak to Our Experts

Strategic Consulting

To develop pragmatic strategies that stand up to health agency scrutiny and account for your business realities.

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Execution Services

We rapidly deploy boots-on-ground or remote teams of talent to implement your defined strategies, anywhere in the world.

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Ongoing Support

We provide training, monitoring, and reviews to help you maintain quality and compliance over time.

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Our success is measured by yours.

Rapid Warning Letter Remediation for a European OTC Manufacturer

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Helping Clients of All Sizes Prepare for EU MDR/IVDR Compliance

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Coaching a Global Biopharma
to Aseptic Manufacturing Compliance

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How can we
help you?

Tell us what you’re looking to achieve.
We’ll put our experience to work on your specific problem.

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Insightful Resources

Featured Case Study

Deploying Remote Teams for 100% Virtual Project Delivery

Explore the Outcomes