Regulatory Compliance & Validation for Life Sciences

Arbour Group has been a trusted global advisor to over 300 life sciences companies to deliver risk-appropriate solutions and methodologies that support organizational goals and objectives. We have developed proprietary validation package solutions for major enterprise software systems and have deep regulatory expertise to ensure ongoing compliance in an evolving digital technology landscape.

Software Validation & Testing

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

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Quality Assurance

We utilize our proven risk-based methodologies along with regulatory guidance to ensure compliance with industry standards to include 21 CFR Parts 11, 211 and 820, as well as with industry best practices.

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Digital Compliance

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

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Digital Innovation

Our expert consulting perspective and digital strategies identify process improvement opportunities to ensure effective digital business innovation solutions.

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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.

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