We offer full-service product development and CMC regulatory consulting services for pharmaceuticals. Our experienced team of experts are ready to provide assistance across CMC disciplines at all stages of drug development.
Magothy Consultants have extensive experience in Intellectual Property development, including specification development and as a fact witness in defense of issued patents. In addition, we have expert witness experience in patent litigation cases, including Expert Reports, deposition, and court testimony.
Our drug product consultants have a substantial background in formulation & process development, scale up, and commercialization of various drug products. We can guide:
Magothy consultants have extensive experience in drug product development, including the associated regulatory briefing documents, meetings, dossier preparation and defense. These activities include:
Magothy Consultants unique background allows us to provide our clients with detailed and thorough due diligence audits. We help clients through:
We have expertise in process chemistry to support phase-appropriate chemical and process development, including:
We provide project management support for:
We can provide structure to better delineate deliverables and project milestones with activity oversight, project planning, and coordination.