Particle Analysis Experts.

Cutting-Edge Parenteral Testing Services for the Biotech and Biopharma Industries.

Parenterals Analysis

Providing FDA-inspected, cGMP facilities that support and debottleneck each step of the drug development process on your journey to market.

Medical Device Analysis

ISO & USP particle testing methods adapted for infusion and transfusion equipment for medical use, containers, & needle-based systems for intravenous injections.

Extractables & Leachables

E&L services for pharmaceuticals, and medical devices, including method development and validation, impurity identification, and more. 

Speak With Our Lab Experts

Accelerating your mission to provide patients access to life-saving medicines.

Gateway Analytical is an FDA-registered and inspected cGMP laboratory focusing exclusively on parenteral testing services across process and formulation development, product-package validation, clinical and commercial manufacturing, quality control and release testing, stability testing, and regulatory support. Our services de-risk product development and accelerate speed to market for new life-saving treatments. We offer decades of specialized experience in visible particle characterization, subvisible particulate release testing, container closure integrity testing (CCIT), extractables and leachables (E&L) testing, and more, on your journey to market.

Chemical & Materials Analysis Specialists.

We adapt our facilities to meet our customers’ needs! We are prepared to handle cytotoxic and chemotherapeutic medicines, HPAPI drug substances, attenuated viruses, human blood-derived products, and DEA Scheduled II-V products.

Our greatest assets are the investments we make in our people, our facility, and our partnerships. We invest in the people who are essential to our success & our scientists are eager and committed to our mission and culture. Boasting certifications and accreditations from leading institutions; partnership drives Gateway Analytical. Our strongest partnerships are forged between CDMOs, license holders, and biosimilar companies with the aim to advance access to life-saving medicines for patients.

Our 17,000 sqft. facility is site-inspected and proven to meet the highest regulatory body expectations.

When you get your start serving pharmaceutical drug developers, you don’t just build another analytical lab. You build the best. We hold accreditations and certifications from the U.S. Food and Drug Administration (US FDA), U.S. Drug Enforcement Administration (US DEA), International Organization for Standardization (ISO), Health Canada, and the European Medicines Agency (EMA).

Highly Specialized Parenteral & Medical Device Testing Services. FDA-Inspected Facilities. 100% cGMP-Compliant Testing.