Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy?
Biovian's CEO will be Available for Discussions at Three Events in Europe
Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe.
Measuring Zeta Potential for Product Stability and Performance
Cosmetics, paints, inks, paper, drug delivery, personal care, food or intra-lipid emulsions are made up of multi component chemistries. Most products go through a stage where different phases co-exist such as emulsions, suspensions or dispersions and as such require a specific amount of stability in order to meet expected performance criteria.
Six Must-Read Scenarios for FDA Consulting
FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for further drug and device development.
Morphologi G3-ID Used by FDA to Approve a New Nasal Spray
Key data for the approval of a nasal spray containing mometasone furoate has been obtained by the Food and Drug Administration (FDA) through the use of Malvern's Morphologi G3-ID system.