Comprehensive Finished Product Testing and Batch Release Services
Ensure your finished product meets critical specifications consistently. Our team is dedicated to verifying the production of your drug product, maintaining its intended use, quality, and performance characteristics.
Despite the increasing complexity of therapeutic molecules, derived from diverse synthesis processes, we possess the expertise and infrastructure to support your unique drug product. We handle various therapeutic ingredients, including small molecules, biologics, nucleic acid-based therapeutics, and combination products.
Our experience extends to a wide range of dosage forms, encompassing sterile injectables, ophthalmic, topical, transdermal, oral solid and liquid, inhalation, and drug-device formulations.
Batch Release Testing
Routine quality control (QC) testing is a crucial component to drug product batch release. Our expert team ensures your finished drug product meets established specifications and that the purity, integrity, efficacy, and concentration in each lot are consistent through a variety of testing procedures. Our testing verifies product compliance is met to safeguard patient safety and to advance your finished product into the market faster.
We support a diverse range of drug products and have experience applying guidelines from various regulatory bodies. Whether you have developed a small molecule, biologic, nucleic acid based therapeutic, or combination product, partner with us for the dedicated finished product testing needed to maintain your operations.
Cleaning Verification
Confidently move your drug to market with our meticulous cleaning verification. We analyze surfaces for microscopic trace contaminants to ensure your processes maintain compliance.
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.