Trusted Compendial Testing to Global Standards
Ensure your raw materials and drug product meets global standards with our compendial testing services. Compendial standards define the quality, purity, strength, and identity of pharmaceutical raw materials and finished products. These standards are established and maintained by authoritative pharmacopoeias or compendia organizations, which differ between countries.
Compendial testing can be challenging, as it requires significant resources and expertise. Our GMP testing capabilities meet multiple compendial standards to ensure the quality and safety of your pharmaceutical and biologic products.
Our testing services comply with the requirements described in the most commonly referenced compendia, including:
- United States Pharmacopoeia/National Formulary (USP/NF)
- European Pharmacopoeia (EP)
- British Pharmacopoeia (BP)
- Japanese Pharmacopoeia (JP)
- Japanese Pharmaceutical Excipients (JPE)
- Chinese Pharmacopoeia (ChP)
- Food Chemicals Codex (FCC)
- American Chemical Society, Reagent Standards (ACS)
Navigating Regulatory Compliance & Pharmacopoeias
To ensure your product consistently meets the highest quality and safety standards, we incorporate three crucial elements – verification, meticulous adherence to compendial procedures, and expertise in interpreting and applying pharmacopeial monograph requirements.
Verification
Our testing services include rigorous verification of compendial procedures, ensuring that the methodology used on your materials yields reliable and acceptable results. We verify compliance with established pharmacopoeias and regulations, providing you with the assurance that your products meet the most stringent requirements.
Compendial Procedures
We follow compendial procedures meticulously, ensuring that every aspect of testing, from sample preparation to analysis, adheres to the standards set by pharmacopoeias. Our commitment to these procedures guarantees that you receive accurate, reliable results.
Monograph
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.
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.