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Quality Compliance & Auditing

Professional Services / Regulatory and Compliance / Compliance and Audit Services

Achieve Regulatory Compliance & Quality Assurance

Our team of experienced consultants is dedicated to helping you achieve regulatory compliance and quality assurance, while optimizing your business processes and performance. 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. Trust our pharmaceutical compliance consulting team to offer the customized support you are searching for.

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QA/QC Services

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GMP Compliance

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
  • Training Programs for Compliance & CAPA
  • Remediating Audit or Inspection Findings

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

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

Your Trusted Quality Assurance Consultants

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.

Integrated Professional Services

When your team needs additional support, we are ready to jump in to meet demand. Our diverse range of expertise allows us to aid in a variety of projects and programs.