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.
Gateway Analytical is a cGMP-compliant laboratory with ISO 9001 and ISO 17025 accreditations that provides industry-leading pharmaceutical analysis services tailored to support your unique drug development projects. Our FDA-inspected laboratories are licensed with the DEA to accept Controlled Substances (Schedules II, III, IV, V) and are even equipped to handle and isolate particulate from cytotoxic drug materials. And as the pioneer of Raman techniques for ingredient specific particle sizing, you can have full confidence that our innovative, forward-thinking experts will be ready to tackle your team's toughest challenges.
Patients rely on your product to improve their daily lives.
You can rely on Gateway Analytical to ensure your product delivers -- contact us today.