Regulatory Compliance & Validation for Life Sciences

Arbour Group delivers software assurance and lean validation and verification products and services that simplify compliance. For over 25 years, Arbour Group has assisted Life Sciences companies with FDA 21 CFR Part 11 and EU Annex 11 requirements.

We help life sciences companies ensure that key business systems are functional and in full compliance with applicable FDA and international regulations and guidelines.

Learn More

Managed Services

We provide cost-effective, scalable resources to perform IT compliance services on a part-time or full-time basis.

Learn More

Digital Compliance

We focus on the processes and technology that will exceed your digital compliance needs while aligning programs with your industry regulatory requirements.

Learn More

REQUEST INFORMATION

WHO WE WORK WITH

Pharmaceutical

We assist pharmaceutical companies with the management of business risk related to compliance with the requirements of the FDA and other international regulatory agencies.

Medical Device

We assist medical device companies with compliance related to the requirements of the FDA and other international regulatory agencies as well as the guidelines contained in ISO 13485, Quality Management Systems and ISO 14971, Application of Risk Management to Medical Devices.

Biotechnology

We provide assistance to Biotechnology companies related to managing the risk associated with the development and manufacture of drugs, vaccines and antitoxins.

Diagnostic

The Diagnostics segment of the life sciences industry is one of the fastest growing. Companies in this segment develop the reagents, instruments and systems that are intended to diagnose disease as well as disease mitigation, treatment or prevention.

RESOURCES