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Archana Nagarajan

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Germany

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1 to 4 of 4 total
Posted By Archana Nagarajan 16-Sep-2020 02:50
Found In Egroup: Boston Chapter
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We are currently finalising the IND application for one of our products that is based on US standards and a Monograph, for which we are planning to perform clinical trials. As all ingredients (i.e. API + and excipients) are compliant with their governing ...
Posted By Archana Nagarajan 17-Jul-2020 03:25
Found In Egroup: Boston Chapter
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Dear Fiona, Thank you for such a detailed response. Pre-IND is not an option due to the amount of time required there. After getting all the great advise here, we have finalised our strategy and let's see how that goes.  Thank you very much! Yes, I am in Germany but working for a US consultancy. ...
Posted By Archana Nagarajan 16-Jul-2020 14:28
Found In Egroup: Boston Chapter
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Hi Mark,  Thank you for your response. We are now finalising our rationale based on all the feedback we have received here.  I am in Germany, but work for a US consultancy and they act as agents when the clients need it. However, I will connect with you on LinkedIn! Thank you Best ------- ...
Posted By Archana Nagarajan 14-Jul-2020 10:52
Found In Egroup: Boston Chapter
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Dear Fellow Community Members, we have a question regarding the application of FDA IND requirements on an API manufacturer. We are preparing an IND (Phase 2-3) for a drug product where we are unable to obtain detailed information on the manufacturing process at the supplier's facility. Meanwhile, we ...