Our mission is to help organizations achieve and maintain the highest standards of quality, regulatory compliance services, and scientific data integrity, particularly in the context of GxP regulatory references. We are dedicated to providing practical, risk-based quality assurance solutions for life sciences that support innovation while ensuring compliance with global regulatory requirements.
Through collaboration, continuous improvement, and the thoughtful application of emerging technologies, including artificial intelligence (AI), we assist our clients in navigating complex regulatory environments with confidence, preparing for successful inspections, audits, and regulatory submissions.
Integrity — We uphold the highest ethical, scientific, and regulatory standards in every engagement, ensuring our approach aligns with GxP regulatory references.
Excellence — We deliver practical, high-quality solutions that exceed client expectations while standing up to rigorous regulatory compliance services scrutiny.
Partnership — We build trusted, long-term relationships founded on collaboration, transparency, and shared success in life science quality assurance.
Commitment — We are dedicated to protecting research integrity, ensuring regulatory readiness, and empowering our clients to succeed with utmost confidence.
With a focus on life science quality assurance, our expertise spans a wide array of scientific and regulated disciplines, including medical devices, toxicology, pharmacokinetics (PK), pharmacodynamics (PD), safety pharmacology, avian toxicology, vector-borne disease research, reproductive toxicology, animal lab, field and wildlife studies, as well as bioanalytical and analytical studies.
Our extensive experience includes offering regulatory compliance services to contract small- and large-scale research organizations (CROs), universities, research institutions, and government agencies across the US and internationally.
Good Laboratory Practice (GLP) is essential in the realm of life science quality assurance and encompasses important GxP regulatory references such as 21 CFR Part 58 (U.S. FDA), OECD Principles of Good Laboratory Practice, and EPA GLP Regulations (40 CFR Part 160 and 792).
Good Clinical Practice (GCP) is essential for ensuring regulatory compliance in clinical trials. The guidelines outlined in ICH E6(R2) Good Clinical Practice, currently transitioning toward E6(R3), along with GxP regulatory references such as 21 CFR Parts 50, 54, 56, 312, and 812.
Computerized Systems & Electronic Records play a crucial role in life science quality assurance. Key GxP regulatory references such as 21 CFR Part 11, along with the FDA Guidance on Computer Software Assurance (CSA) and GAMP® 5, Second Edition, are essential for data quality & integrity.
Good Manufacturing Practice (GMP/cGMP) encompasses essential GxP regulatory references such as 21 CFR Parts 210 and 211, the 21 CFR Part 600 Series for Biologics, the EU GMP Guidelines (EudraLex Volume 4), and the PIC/S GMP Guide.
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