Ross Consulting LLC

Services: -CMC Advisor (Entrepreneurial spirit to help startups and biotech) -Board Member (Futurist, CMC visionary) -Strategy and Development for Drug Product (and Drug Substance as needed w/ collab) -Project management and daily execution -New molecular entity - due diligence for in-licensing, proposing molecule modifications, and providing technical rationale for out-licensing -Strong formulation scientist for oral solids, sterile injectables, medicated feeds, and transdermal -Known for work on palatable dosage forms (soft chews, granules, medicated food for cats, dogs, swine, and horses) -Palatability study design: Acceptance vs. Preference studies -Experienced with small molecules to proteins Background: I am a drug product CMC advisor known for challenging the status quo and making a difference for companies to get to market. I have managed over 30 programs, had 12 FDA approvals, and assisted with 7 products getting commercialized (mainly new molecular entities or branded products). A major strength I have is identifying risks and either avoiding them or mitigating, such that on average I have saved 6 months and up to $1MM.