pharmaceutical gap analysis is the most effective route for designing and finalizing a drug development program. with a higher risk of failure, greater uncertainty and more expense, there is a need for an optimized strategy to better utilize the resources, time and money to get the drug to the market. a gap analysis identifies any missing elements in the data providing specific action items to fill those gaps before submitting the application to the regulatory agency. with the help of our experts, we have developed an extensive list of questions that regulatory agency reviewers seek.
thus, we can assist in the evaluation of your drug program and tackle any potential gaps prior to you meeting with the regulators at the end of phase 1, phase 2 or pre-nda. we will recognize the potential research and development (r&d) or regulatory challenges related to the molecule, therapeutic area, and competitive landscape. we assist in creating a clinical pharmacology development program in line with regulatory filing strategy. at concept 2 clinic, we understand that time, money and resources are always constrained in drug development.
this study aims to determine the prioritization of drug development in indonesia through the evidence-based policymaking process in order to close the distance between stated policy goals and the realization of planned goals. the indonesian government has provided funding, resource support, tax incentives, promotions and a facilitating roadmap for drug development [12], however, there is only a small number of indonesian pharmaceutical industries engaged in r&d. strategies must be developed in order to avoid a gap between the expectations of a policy and its actual outcome. a conceptual model was developed to identify gaps in the point of views of the pharmaceutical industry and the government. a total of 200 questionnaires were electronically distributed to the top-level pharmaceutical industries and relevant government institutions, identified by the database of indonesian drug regulatory authority (dra).
the factors contributing to the current performance of drug development in the order of priority are pull strategies, market, regulatory pull strategies, push strategies, regulation, pharma capacity, and drug characteristics. the result of this computation is summarized in table 4, and was used to create the importance-performance map as shown in fig 4. leaders in both the government and pharmaceutical industries agreed that all elements are drivers for drug development. one possible explanation for this finding could be associated with the regulatory pressures in indonesia, driving pharmaceutical industries to be more focused on regulatory requirements of drug characteristics (safety, efficacy and quality). this study clarified the importance of integrating policy, research and policy implementation, by identifying the problems in drug development that need to be prioritized.
gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance. pharmaceutical gap analysis is the most effective route for designing and finalizing a drug development program. a new drug development process can be a a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance to, gap analysis example, gap analysis example, gmp gap analysis checklist, gaps in pharmaceutical industry, gap analysis pdf.
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