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Meridian BioGroup, now a Pace® Life Sciences company, can help you achieve regulatory compliance and optimize your business.

Our team provides high-quality compliance, regulatory, and validation services to the biotechnology and pharmaceutical community. Our mission is to deliver extraordinary service offerings precisely aligned with our client's requirements. With a thorough understanding of biotech and pharmaceutical operations, and the regulatory challenges facing these industries, we have the experience, the skills, and the talent to provide efficient and cost-effective solutions. We strive to develop long-term relationships in the biopharma community.

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your goals

Whether you’re a start-up that requires high-level consulting about compliance, regulatory, or validation strategies or an established organization with targeted requirements for a specific project, you have a vision for achieving your organization’s milestones.

our approach

We learn about your business, project, and methodologies, then provide you support with our technical skills, professional demeanor, and attention to detail. Our talented personnel are committed to understanding your needs and delivering practical validation, regulatory, and compliance outcomes.

handshake icon_gravity blueVALIDATION

Full compliance with regulatory requirements is the cornerstone of successful product development. From FAT support to high-level validation approaches to detailed on-site services, our professionals can help with the validation of:

  • Facility Systems
  • Process Equipment
  • Lab/Analytical Equipment
  • Computer Systems
  • Manufacturing Processes and More


Successful compliance requires knowledge of the current regulatory environment and effective quality/risk management. We can help with:

  • Assessing Existing Quality Systems
  • Conducting Risk Assessments
  • Developing Effective and ‘Right-sized’ Compliance Programs and Quality Systems
  • Ensuring best practices in cGMP, GLP, GTP, ISO, CLIA

elearning_gravity blue MASTER PLANS

An effective validation master plan ensures aligned expectations, informed commitments, and improved budgeting, scheduling and project management. Our experts can help develop a plan to:

  • Meet Regulatory Requirements
  • Coordinate Commissioning, Qualification, and Validation Activities
  • Control Cost and Schedule
  • Ensure Best Practices

The science of teams

We align people to process; passion to productivity. Our elite teams love working for us — and they love working for you.



They manage expectations and stressful situations born from a reduction in head count — but not in work load. They have been inventive in reducing overtime by working in overlapping shifts. The work is getting done and we are meeting our timelines.



audit_gravity blueAUDITS

Credible audits are essential for demonstrating and maintaining compliance. Our professionals can help with:

  • Third-party Audits and Supplier Selection Audits
  • Benchmarking and Gap Analysis
  • Quality Improvement
  • Regulatory Inspection Readiness
  • Critical Phase Inspections

protected_gravity blueREGULATORY

Our experienced regulatory consultants can assist with early stage strategy discussions through IND submissions, for US, EU and Rest of World, including:

  • Technical Authoring or Review of Regulatory Submissions
  • IND, CTA, IMPD, QOS, Protocols, IB, ICFs
  • FDA Meeting Strategy, Process, and Submission Packages
  • Project Management of Cross-functional
  • Teams for IND Development
  • Guidance on Expedited Pathways


management benefits - gravity blueTRAINING

We can help develop and promote employee behavior that aligns regulatory requirements with business goals, including:

  • Training for GXP Compliance
  • Quality Assurance Strategies
  • Report-writing, Deviation-reporting, and Root Cause Workshops

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