Pharmaceutical assets are often represented as being at an advanced stage with a near term commercialization horizon; however, manufacturing programs can be the source of unexpected regulatory delays or budget overruns.
Investors and Licensees can mitigate risk, assign appropriate valuations, and identify points for deal negotiations by conducting a comprehensive audit and gap analysis of a target company’s manufacturing and quality program.
Our CMC consultants know the common pitfalls and can identify potential weaknesses that could interfere with meeting regulatory requirements necessary to continue the clinical trials or obtain market approval.
You receive a written report and risk assessment of the CMC program highlighting any areas of potential concern which may threaten pharmaceutical asset value.
Production Assessment and Cost of Goods Analysis
DS InPharmatics provides an objective assessment of Cost of Goods (COG) estimates and the capability of current manufacturing scale-up and production to meet clinical and commercial forecasts.