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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):

  • Performing technical pre-clinical and/or discovery research activities

  • Performing technical research to improve identification of potential drug and/or therapy applications .

  • Performing technical research of a lead compound and/or class of compounds identified requiring testing and evaluation in animal models of the disease

  • Performing materials science research (e.g. alternative application of existing chemicals) in direct support of new or existing product / processes development advancements

  • 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

  • Performing collaborative technical development pursuant to partnering initiatives for R&D, subject to contractual terms and conditions

  • Developing new and/or improved pharmaceutical products (e.g. therapies, medicines or drugs) or technical processes 

  • 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.

  • Developing dose and/or dosing protocols to evaluate magnitude and duration of therapy effect

  • Developing improvements in product design (new formulas, enhanced production yield, product durability, etc.)

  • 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

  • Developing technical screening techniques of compound(s) on specific target(s) during potential therapeutic application 

  • Developing enhancements in process design, optimization, automation, and control

  • Developing new and/or improved product engineering manufacturing techniques and packaging designs 

  • Developing hardware / software system(s) in direct support of R&D activities

  • Developing technology for compliance with various regulatory agencies

  • Designing enhanced therapeutic molecules and/or synthesis to assist testing and experimentation procedures

  • Designing new and/or improved identification techniques of molecular "targets" within particular disease processes

  • Designing enhanced administration and/or dosage protocols to lower drug attrition rates

  • Designing alternative structures of therapeutic compounds through chemistry techniques to create more potent and targeted applications

  • Designing and developing the configuration for a packaging system to be used in transporting a consumer drug product

  • 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)

  • Designing personalized treatments, as opposed to single-disease technologies

  • 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

  • Evaluating the drug’s preliminary acute safety prior to transitioning from technical research into pre-clinical development

  • 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

  • Evaluating experimental drug product manufacturing processes to enhance production activities

  • Experimenting with alternative process methodologies to formulate an improved multi-component packaging system

  • Evaluating alternative materials (e.g. paper, plastic sheet) for use in the construction of packaging system(s) for product to meet FDA storage requirements

  • 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

  • Testing the drug candidate’s absorption when administered to animal and/or human metabolic rate and elimination process

  • Testing a developmental compound for safety using first trials in animals and/or humans, including tolerance and pharmacokinetics

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