Strategies & Solutions to Help You Ensure GxP Regulatory Compliance and Inspection Readiness
Bonum Consulting helps companies navigate complex global regulations, achieve their quality goals and maintain best practices.
With expertise on early development to commercialization across the biotech, medical device and pharmaceutical industries, we partner with you to build compliant quality systems and to prepare for and manage regulatory inspections.
We assist our clients in being successful across GxP Quality (GCP, GMP, GVP, and GLP), bringing solutions to organizations of all sizes.
How We Help You Simplify Regulatory Inspections
We help organizations save time, stress less, and feel confident.
From gap assessments to storyboards to interview sessions, Bonum Consulting works with your subject matter experts (SMEs) to be prepared for inspections.
We can manage and support during the inspection from the “back room” to the inspection room, even assisting with inspection findings.
Know What to Do to Ensure Compliance
Whether improving or coming up with your own Quality Management System (QMS), it can be overwhelming.
Bonum Consulting has the expertise to help you ensure compliance with industry regulations across all phases and all stages. Allow us to review your processes and procedures, design a QMS tailored to your organization’s needs, or improve your existing QMS.
Get GxP Quality Leadership and Support to Strategically Grow and Thrive
Bonum Consulting partners with you to achieve and maintain GxP regulatory compliance and inspection readiness. Whether you need a go-to-resource or a Head of Quality, we provide the solutions and strategies when you need them.
Understanding the Changing Global Quality Landscape
We understand the biotech, medical device and pharmaceutical industries are constantly changing and evolving across the global marketplace as technologies are developed, new diseases are targeted, and the demands of regulatory agencies evolve. We guide our clients through the changing regulations to help ensure quality goals are met and global compliance is maintained throughout their organizations.
What if achieving your organization’s quality goals and maintaining compliance was easy?
With Bonum Consulting, it can be!
Frequently Asked Questions
Our organization has received an audit/regulatory agency inspection finding. Can you help us?
We work with our clients to resolve audit and regulatory agency inspection findings. We can help you understand the significance of the finding, provide strategies to remedy problems arising from the noncompliance, and assist you in ensuring compliance in the future. Our services include agency responses, design and implementation of corrective and preventive action (CAPA) plans, and review of systems and processes.
How can you help us build quality in from the beginning?
We approach quality from the point-of-view that it shouldn’t be audited in, but rather an organization will be most successful if it builds quality in from the ground up. We offer strategies to help organizations ensure GxP compliance from the beginning, including QMS design services, gap analysis, risk assessment, and inspection readiness. We help our clients “do quality right” so that they are always prepared if an inspector were to walk in the door unannounced.
