Targeted support for the entire healthcare product life cycle

WHO WE SERVE

Advance BioReg serves regulatory, clinical, and compliance needs for regulated healthcare product developers and manufacturers of all sizes.

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WHAT WE DO

Advance BioReg provides resources to businesses in the U.S. and international markets to help them commercialize their products and maintain compliance throughout the entire life cycle.

AUDITS

Assisting with inspection readiness by performing audits and gap assessments, for example:

GMP
EU IVDR/EU MDR
MDSAP
GCP

REGULATORY

Preparation of marketing applications and interaction with regulatory agencies including strategy development, for example:

Submissions
483/Warning Letter/EU Non-Conformity Finding Responses
EU Technical Documentation

QUALITY

Assisting in process development, improvement, training, and coaching, for example:

CAPA/Non-Conformance
Complaints/Post-Market Surveillance
Design Controls

CLINICAL

Support of clinical trials through:

Strategy Development
Protocol Design & Development/Statistical Analysis Plan
Clinical Trial Project Management
Trial Master File Management

WHY CHOOSE US?

We're great at what we do.

Our team of professionals has worked together on regulatory, clinical, and compliance projects for clients large and small for over 20 years. We have a reputation for excellence - and we have earned it!

We put our customers first.

We’ll always recommend the path forward that serves your company's best interests and goals – not ours.

We're efficient.

ABR intentionally avoids the layers of bureaucracy you see at other firms. Our flat structure has enabled us to streamline every aspect of our operations, so we can quickly achieve your desired results.

We're experienced.

We spent years working in industry before we became consultants. Every team member has the hands-on experience and knowledge they need to do the job.

We love what we do.

With ABR, your company is always a priority. You will know the individuals working on your project, and they will know you. We’ll work closely with you every step of the way – and if needs change or challenges arise, you’ll always know exactly whose cell phone to call.

We're hands-on.

Ensuring your success isn't just our job - it's our mission. We thrive on solving problems for our clients. If we can clear that hurdle, smooth that path, open that door, or change that trajectory for the better - that’s a good day’s work. For the ABR team, what we do is so much more than just a profession. It’s a passion.