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.
today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. a clinical pharmacology gap analysis is the most efficient route for designing and completing a clinical pharmacology program. the fda has provided a policy document (the clinical pharmacology and biopharmaceutics mapp) that explicitly defines what reviewers are to look for in new drug applications (ndas) and biologics license applications (blas). several example questions are provided below: spanning all issues related to clinical pharmacology and biopharmaceutics, a gap analysis ensures that you will have a strategy to provide an informed answer for every question, regardless of whether you plan to file an nda, partner with another pharma company, or to inform important data-driven strategy decisions. a comprehensive analysis of your existing data is necessary to evaluate which questions can be answered and which ones still require additional information, as well as recommend the optimal timing for planned activities.
the gap analysis will govern planned and future studies to ensure you get the most value out of your data moving forward. careful planning with the help of a clinical pharmacologist or pharmacokineticist is crucial to avoid missteps in your clinical studies. at the same time that your data is being analyzed for gaps, our clinical pharmacology experts formulate a plan for how to address any unanswered questions. in recent years, the fda has expressed its strong support for modeling and simulation in drug development and to inform decision making. geoffrey banks, ph.d., founded nuventra in 2008 and led the company as both its ceo and as a principal consultant for more than 13 years prior to the acquisition of nuventra by cato sms.
gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance. a gap analysis identifies any missing elements in the data providing specific action items to fill those gaps before submitting the application to the a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance to the relevant, gap analysis in pharmaceutical industry pdf, gap analysis example, gap analysis example, gmp gap analysis checklist, regulatory gap analysis template.
gap analysis/regulatory assessment is used by all the pharmaceutical companies to analyze processes of any division of their company. in this process, we follow all the guidelines of all current practices and make a review for adequacy, suitability, effectiveness, compliance. a gap analysis is an opportunity to evaluate data collected to date and create a plan to address gaps for an acceptable data package to the a conceptual model was developed to identify gaps in the point of views of the pharmaceutical industry and the government. it is composed of the aim and object of using a validation gap analysis protocol in the bio-med and pharmaceutical industries is to identify the gap between the regulatory, gaps in pharmaceutical industry, gap analysis pdf, gap analysis regulatory compliance, fda gap analysis, gap analysis clinical trials, gap analysis framework, validation gap analysis, product gap analysis template, gap analysis tool, sop gap analysis template. what does gap analysis stand for? what is gap analysis example? how do you do a gap analysis in healthcare? what is regulatory gap analysis?
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