Particle Analytical is one of the few laboratories in the world that can conduct Raman analysis under GMP compliance.
This includes particle identification and particle size distribution, enabling us to perform release testing analysis with this advanced technique.
Particle Analytical has been working intensively on the qualification of the Renishaw InVia™ Qontor Raman microscope, and we are proud to announce that we can now offer our services to assist with bioequivalence studies to prove the essential similarity of generic products with originator products using Morphologically Directed Raman Spectroscopy (MDRS).
FDA recommends MDRS
The MDRS method is recommended by the Food and Drug Administration (FDA) for in-vitro bioequivalence studies of nasal sprays. MDRS combines size and shape analysis with chemical identification, making it particularly beneficial for products like nasal sprays, inhalation powders, suspensions, and topical drug delivery systems or other precision-based formulations.
MDRS services performed by Particle Analytical are in accordance with FDA guidelines to ensure regulatory compliance.
