Ensure Safe & Effective Manufacturing with Reference Standards
We support the development and application of reference standards in a manner that considers the unique requirements of your materials and processes. These standards play a foundational role in determining quantitative data, qualitative data, and calibration, which are critical to achieving scientifically valid results. Our team is adaptable to the assays, degradation products, process impurities, resolution standards, and metabolites standards applicable to your drug product.
Characterization
Our team evaluates and thoroughly characterizes intended materials, impurities, or byproducts according to their intended use. When you partner with us, we strike a balance between providing reliable references and streamlining testing when further analysis is not necessary.
Storage & Distribution
Leverage our controlled storage and distribution once reference standards are established to support the ongoing lifecycle of your drug product. Our state-of-the-art facilities integrate seamlessly and efficiently to maintain and monitor ongoing stability.
Integrated Laboratory Services
When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.