This webinar offers attendees insight into how chemically specific analysis using Raman Chemical Imaging (RCI) and other cGMP-compliant analytical services at Gateway Analytical can provide the detailed information needed to get a drug product to reach bioequivalence faster, in addition to providing guidance on how to keep the manufacturing process up to necessary quality standards by identifying out-of-specification and foreign particulate issues.
There are many challenges that India-based generic pharmaceutical drug manufacturers face today, including the ever pressing issue of getting their product into the U.S. market first, which may require the completion of complex in vivo and in vitro studies. With the constantly growing assortment of regulatory hurdles, it’s critical for companies to seek out guidance not only at the drug formulation level, but also the manufacturing level for controlling product stability and safety.
Join Oksana Olkhovyk, Ph.D., Senior Scientist, at Gateway Analytical as she provides a detailed look at the capabilities of RCI and how it can provide detailed chemically specific analysis for a multitude of drug product types including: orally inhaled or nasal drug products, dry powder inhalers, metered-dose inhalers, tablets and semi-solids. Oksana will walk attendees through Gateways processes for not only drug analysis but also how Gateway can help guide companies through the FDA regulatory requirements. This includes addressing drug formulation, manufacturing quality concerns, consulting and product submission support. In addition, real application and case study examples will be shown and discussed.
Topics Covered Will Include
- An overview of Gateway Analytical services, with deep insight into RCI and spectroscopy
- How chemically specific analysis provides the details to establish bioavailability and prove bioequivalence
- Review of the FDA critical path opportunity for generic nasal suspensions formulations
- Application and case study examples of chemically specific analysis