Highly Specialized Parenteral & Medical Device Testing Services. FDA-Inspected Facilities. 100% cGMP-Compliant Testing.
Particle Analysis Experts.
Cutting-Edge Parenteral Testing Services for the Biotech and Biopharma Industries.
Gateway Analytical Helps you Accelerate your Mission to Provide Patients Access to Life-Saving Medicines.
We are 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.
Gateway Analytical offers decades of specialized experience in visible particle characterization, subvisible particulate release testing, container closure integrity testing (CCIT), and extractables and leachables (E&L) testing.
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.

