Bonum Consulting offers a wide range of strategic consulting services and solutions to help your organization compete, grow and thrive.

We help our clients achieve their quality goals and maintain best practices across the life science industry – biotech, medical device, pharmaceutical – from start-up to global leader. We guide our clients from beginning strategy to execution, covering development to commercialization.

We provide the solutions you need across all phases and all stages.

Our Quality Consulting Services:

Regulatory Inspection Preparation, Readiness and Support

Bonum Consulting helps our clients prepare for global regulatory inspections, provides support during inspections and audits, and assists clients with responses to and follow-up with global regulatory agencies. We provide a full GxP (GCP, GMP, GVP, and GLP) regulatory inspection program, including:

• gap analysis
• document review
• inspection strategies
• mitigation and remediation strategies
• preparing interviewees on presentations, questions, and best practices
• training the “back room” inspection team
• storyboard drafting assistance
• on-site management and support during the inspection
• assisting with inspection findings

Quality Management System (QMS) Development

Bonum Consulting offers a variety of GxP Quality Management System services to meet our clients’ needs, including:

• designing and implementing a tailored Quality Management System to meet your organization’s needs, size and strategy
• offering guidance to improve your existing Quality Management System
• reviewing your processes and procedures to identify areas of improvement to quickly strengthen your quality system

Standard Operating Procedure (SOP) Development

At Bonum Consulting, we create custom-designed SOPs to reflect your organization’s internal processes and procedures. Our SOP services include:

• meeting with your team to determine your processes, team member responsibilities, and your organization’s needs
• developing SOPs that are easy-to-understand and that guide your team through procedures without deviation
• tailoring SOPs to your organization to help ensure compliance with existing laws, regulations and guidance
• creating flow charts and procedures to define team member responsibilities
• developing policies and procedures that define the rules and guidelines for essential business activities

Organizational Quality Assessments

Bonum Consulting provides organizational quality assessments to determine how well your organization is adhering to procedures and global regulatory requirements, and to determine the overall effectiveness of your Quality Management System. Our assessments include:

• compliance gaps and risk analysis
• recommendations for improvement based on your development stage, size and needs
• design, development and implementation of a QMS to help ensure your organization is in compliance with procedures and regulatory requirements

GxP Quality Leadership and Support

Bonum Consulting provides global GxP (GCP, GMP, GVP, and GLP) quality support for clients of all sizes across the life science industry. This includes serving as your organization’s Head of Quality.