Pharmaceutical companies may be eligible for R&D tax credits for performing qualified research activities. For example, the following activities may be eligible for R&D tax credits (see also Orphan Drug Credits):
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Performing technical pre-clinical and/or discovery research activities
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Performing technical research to improve identification of potential drug and/or therapy applications .
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Performing technical research of a lead compound and/or class of compounds identified requiring testing and evaluation in animal models of the disease
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Performing materials science research (e.g. alternative application of existing chemicals) in direct support of new or existing product / processes development advancements
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Performing quality testing, technical non-routine data collection, regulatory compliance validation, and facilities redesign for new and/or optimization process development in direct support of R&D activities
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Performing collaborative technical development pursuant to partnering initiatives for R&D, subject to contractual terms and conditions
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Developing new and/or improved pharmaceutical products (e.g. therapies, medicines or drugs) or technical processes
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Developing pilot studies to evaluate efficacy and safety in specific populations of patients with the disease and/or condition to be diagnosed, treated, or prevented.
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Developing dose and/or dosing protocols to evaluate magnitude and duration of therapy effect
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Developing improvements in product design (new formulas, enhanced production yield, product durability, etc.)
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Developing pharmaceutical products and/or therapy pursuant to regulatory requirements (e.g. Food & Drug Administration) in order to submit New Drug Application(s) (NDA) for marketing and manufacturing approval
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Developing technical screening techniques of compound(s) on specific target(s) during potential therapeutic application
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Developing enhancements in process design, optimization, automation, and control
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Developing new and/or improved product engineering manufacturing techniques and packaging designs
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Developing hardware / software system(s) in direct support of R&D activities
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Developing technology for compliance with various regulatory agencies
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Designing enhanced therapeutic molecules and/or synthesis to assist testing and experimentation procedures
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Designing new and/or improved identification techniques of molecular "targets" within particular disease processes
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Designing enhanced administration and/or dosage protocols to lower drug attrition rates
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Designing alternative structures of therapeutic compounds through chemistry techniques to create more potent and targeted applications
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Designing and developing the configuration for a packaging system to be used in transporting a consumer drug product
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Designing new and/or existing production processes or technologies to support existing process improvements intended to increase productivity or reduce costs (e.g. increased product shelf life, reduce side effects)
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Designing personalized treatments, as opposed to single-disease technologies
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Designing technical clinical trial(s) procedures to further evaluate the therapy effectiveness for specific indications and/or applications to improve understanding of safety and drug-related adverse effects
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Evaluating the drug’s preliminary acute safety prior to transitioning from technical research into pre-clinical development
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Evaluating alternate target molecules (e.g. through drug treatment) to prevent, cure, delay progression, restore function and/or improve the condition of individuals suffering from a disease and/or illness
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Evaluating experimental drug product manufacturing processes to enhance production activities
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Experimenting with alternative process methodologies to formulate an improved multi-component packaging system
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Evaluating alternative materials (e.g. paper, plastic sheet) for use in the construction of packaging system(s) for product to meet FDA storage requirements
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Testing pharmacology and toxicology requirements for new and/or improved therapies in specific tissues or animals to establish the effects and mechanisms of developmental drug / therapy candidates
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Testing the drug candidate’s absorption when administered to animal and/or human metabolic rate and elimination process
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Testing a developmental compound for safety using first trials in animals and/or humans, including tolerance and pharmacokinetics