Our Story
Phase 1 Quality Consulting was founded to assist small pharmaceutical companies navigate global GxP (Good Practice) requirements from the beginning of the drug development process. Our team collaborates closely with CMC (Chemistry, Manufacturing, and Controls), Regulatory, and Product Development departments to create fit-for-purpose quality systems for drug products used in clinical trials. With a foundation built on industry expertise and a commitment to excellence, we aim to empower companies to achieve regulatory compliance and prioritize patient safety.
We see ourselves as a forward-thinking team of dedicated pharmaceutical quality professionals with the expertise to match.
Why Choose Us
Expertise in GxP Compliance
With extensive experience in GMP, GLP, and GCP, Phase 1 Quality Consulting provides expert guidance to navigate complex global GxP requirements and ensure regulatory compliance.
Tailored Solutions
Phase 1 Quality Consulting develops robust, customized quality management systems to meet the specific regulatory requirements and operational needs of pharmaceutical companies.
Flexible Engagement Models
Offering adaptable support options, Phase 1 Quality Consulting accommodates your organization's needs and budget with short-term consulting, ongoing assistance, or embedded resources.
Continuous Improvement and Proactive Approach
Committed to excellence, Phase 1 Quality Consulting continuously optimizes quality systems, ensuring they evolve with industry trends and regulatory updates.
Our Expertise
With our extensive experience from both large and small pharmaceutical companies, we assist clients in building, maintaining, or remediating quality systems. Our broad level of global experience in GMP, GLP, and GCP quality systems allows us to provide fit-for-purpose solutions with the right level of guidance. Our deep knowledge of drug, biologic, and device requirements ensures that we can address your unique challenges effectively.
Our Expert Team
Our team at Phase 1 Quality Consulting comprises seasoned professionals with extensive experience in pharmaceutical quality assurance, dedicated to delivering customized solutions and ensuring regulatory compliance.
Tim Reinhardt
Contacts
140 Preston Executive Drive, Suite 100B, Cary NC 27513
(984) 833-8414