Choosing and proficiently managing vendors that are reliable, in addition to being technically competent, is an optimal tool to have to minimize the time required to develop and register a drug or healthcare product. Contract manufacturers, laboratories, and suppliers need meticulous oversight and management in order to avoid development delays and overruns in cost, and to guarantee the quality of products and deliverables.
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Production cost predictions and cost of goods analysis
The real costs of production in the pharmaceutical industry are hard to determine. DSI has industry-experienced professionals available to help businesses discover, analyze and in several cases decrease real costs of API and Drug Product manufacturing.
For synthetic APIs, analysis at DSI includes a detailed literature search, patent inquiry, analysis of synthetic routes and yields, analysis of starting materials, production facility and/or specialized processing requirements, labor requirements, etc.
DSI experts prepare an in-depth manufacturing cost prediction that, with the fundamentals above, will include thorough consultation and discussion on the challenges characteristic in the identified routes, material possibilities and the estimated cost of the final API/intermediate.
For biologically produced APIs (large molecules and secondary metabolites), DSI considers the method provided or a practicable process model resultant from literature. For drug products, the formulation provided or a formula from published regulatory documents are considered to predict the cost of producing the product form(s). Costs for packaging in any trade dress can be predicted, including the cost of serialization.
DSI’s three levels of cost analysis services
- Cost prediction of API or Drug Product by a single process with basic background information and discussion of the foundation of the prediction
- Cost prediction of API or Drug Product with a consultation of a process, thought given to alternative processes, including background information and discussion of the foundation of the prediction with supporting tables and graphs
- Cost prediction of API or Drug product with a thorough discussion of the prediction, presentation slides, and research into particular issues. (Necessitates a comprehensive discussion with the client to jointly agree on all deliverables.)
DSI provides access to a cost model(s) for client-driven “what-if” analyses of the effect of yield efficiency, throughput, and main material prices.
Cost analysis advantages
- Be able to understand the challenges of chosen methods
- Analysis of specific production and equipment needs for material development and manufacture
- Be able to identify starting material supply costs and find challenges
- Critical Analysis of “Make vs. Buy”
- Geographic location variables in production (global analysis)
- Support with most cost-effective method for wanted production volume
- Focus on “Cost Drivers” (suitable development efforts to decrease overall costs)
- Provision of a detailed understanding of final API or Drug Product cost predictions
- Established pharmaceutical companies
- Emerging pharmaceutical and Biotech companies
- API sourcing professionals
- Generic API manufacturer
Choosing and effectively managing vendors that are reliable, in addition to being technically competent, is an optimal tool to have to minimize the time required to develop and register a drug or healthcare product.
Contract manufacturers, laboratories, and suppliers need meticulous oversight and management in order to avoid development delays and overruns in cost and to guarantee the quality of products and deliverables. DSI cooperate with vendors and clients to identify suitable and place the needed management methods to decrease the risks and optimize the value that these service providers can generate.
DSI has a network of contract manufacturing organizations (CMOs) which allows them to identify the most appropriate service providers for a business’s compound and dosage form and guarantee best performance within the desired time and budget parameters.
During the whole process, DSI experts recommend formulation and design, manage site inspection/monitoring, design/review protocols and identify the optimal method validation strategy to guarantee compliance with FDA and ICH guidelines. This is a vital step for first-cycle review.
Active pharmaceutical ingredient (API) vendor management
- CMO sourcing
- Specifications and test methods
- Method validation
- Process impurities evaluation
- Stability testing and results analysis
Management of clinical trial materials
- Management of CMO and technical direction
- Formulation oversight
- Selection and characterization of raw materials
- Pre-formulations (chemical/physical properties testing and evaluations)
- Formulations (chemical/physical properties testing and evaluations)
- Development and validation of methods
- Impurity profiling
- Release specifications and testing
- Production and release of clinical batches
- Packaging and labeling of clinical supplies
- Container/closure systems testing and evaluations
- Stability procedures, specifications, tests and results
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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