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 offer the customized support you are searching for.
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
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.
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.