Experience:I'm having more than 22 years of proven experience in providing technical consulting, solutions and services for various industry verticals. I believe that Process control & Process Optimization is core need to every organization which will reflects on their walls and regulating the unwanted costs which is a perennial issues across the Industries. I perceive that Simulations for commercialized drugs before they go for bulk drug development will reduce the experimentation efforts and derives a scientific & structured approach which will lead to an effective business.Issue in the Pharma Industry:Industry Challenge with the ever increasing complexity of formulations, it is inherent that production of such products at large scale brings up several challenges, which includes batch failure due to unmet needs of specifications, flow issues, non-uniformity, fill volumes, material calibrations, etc., which usually causes loss of material due to multiple randomized experimentation which in turn contributes to increase in trial batches effort; content uniformity issues which leads to batch rejection by FDA, unawareness on right operating conditions due to lack of science principles. How are we doing a Value Addition:PharmaDEM primarily focuses on “Development and integration of structure & property based simulations to enable drug product design, with a focus on innovation. Properties of interest are Solubility, Material compatibility, API-Formulation stability, Permeability, Aggregation, Genotoxicity, Blend Uniformity and Packaging. Deep understanding & analysis from Chemistry & Physics stand point will deliver nearest expected results both in formulation & scale up to prevents from unnecessary experimentations. PharmaDEM's capability of cross functional computational modelling, and its expertise in drug design, engineering, chemistry, and formulation modeling will show long term impact and overcomes complex business & manufacturing challenges. Failures, during formulation development due to material compatibility, and failures due to poor flowability are primary road blocks, which prevents to reach expected product outcome. PharmaDEM employs 3 dimension view on product through Chemistry Modelling, Physics Modelling, Engineering Modelling to identify the design space with optimum process parameters & operating conditions. The results through this approach helps in reducing the risk of failures at drug development & drug scale up stage and improves time to market. Predictability is high, Rationale is made clear and Randomization is avoided.