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 34617 PDF STATE APPLICATION INDIANA CONTROLLED SUBSTANCES REGISTRATION 1997

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are you planning to start a clinical trial for a new drug or biologic in usa are you confused about fda regulatory requirements for inds and not sure about the correct regulatory strategy to pursue for your ind in usa global regulatory partners has the perfect solution for you our regulatory affairs team has more than 20 years of experience working with us fda and have prepared and cleared over 100 inds for different drugs and biologics for your ind global regulatory partners can perform the following activities for you step one perform a gap analysis grp team will assess the available preclinical and cmc information that you have collected for your new drug or biologic in order to assess if it's enough for ind application step 2 define the regulatory strategy for your ind application based on the outcome of the gap analysis the team will define the appropriate regulatory strategy for your ind submission to fda if the outcome of the gap analysis shows that the available pre-cli

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