REGULATORY & COMPLIANCE

Quality Compliance & Auditing

Successful manufacturing operations are based on establishing GMP compliance, developing and implementing Quality Management Systems, and performing third party audits to support your requirements.

Services For Your Lab  /  Quality Compliance & Auditing

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 provide the customized support you are searching for.

QA/QC SERVICES

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
AUDITS

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
TRAINING

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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YOUR TRUSTED VALIDATION 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 LABORATORY SERVICES

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.