Gateway Analytical LLC
2009 Kramer Road
Gibsonia, PA 15044 USA
T: (724) 443-1900
F: (866) 658-1445
E: Info@gatewayanalytical.com
Twitter: @gatewaytweets
LinkedIn https://www.linkedin.com/company/gateway-analytical/
W: www.GatewayAnalytical.com

 

Gateway Analytical is an innovative analytical laboratory that specializes in providing expert testing services to the pharmaceutical, medical device, and materials science industries. Built with quality as our cornerstone and timeliness, and customer service as our core values, we are able to offer project turnaround in as fast as 24 hours in a GMP-compliant environment. Our new, fully equipped 8,000-sq-ft laboratory space features HEPA-filtered controlled environments, ISO 9001 and ISO 17025 accreditations, specialized sample preparation capabilities, and a dedicated space for handling cytotoxic drug materials. Gateway is able to provide industry leading materials analysis services tailored to support a variety of unique drug development projects.

 

Identify Foreign Particulate

We identify and source foreign particulate using:

– Microscopy (optical, polarized light, fluorescence)

– FTIR spectroscopy

– Raman spectroscopy

– SEM-EDS

Count, Size & Identify Particle Populations

We count, size, and characterize your wanted (API, excipients, etc.) and unwanted (foreign particulates) particles using:

– Light obscuration (HIAC)

– SPE (automated Raman/LIBS)

– Automated SEM-EDS

– Raman Chemical Imaging

Specialized Testing Services

We provide specialized testing services, such as:

– Chemically specific counting, sizing, and identification of API, excipient, and foreign particles

– API distribution using automated SEM-EDS

– Glass delamination

– Cytotoxic materials handling

– Cleanroom garment shedability testing

Provide Support for R&D, Specialized Projects & Method Transfer

Drug development is more than just clinical trials. Our pharmaceutical analysis services provide support for your company at all stages of development, from preclinical decisions to post-market regulatory inquiries. Pharmaceutical products are evaluated on two critical metrics: efficacy and safety. While these two measuring sticks guide your clinical trials and determine primary and secondary endpoints, you know there are many more metrics that contribute to successful drug development. The quality of raw materials, the particle size distribution of drug ingredients and even the composition of a storage container can affect process outcomes. These data points may not make headlines, but they can make or break an application for marketing approval. To learn more about Gateway Analytical and how we are helping to make the world healthier and safer, visit our website at www.gatewayanalytical.com.