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IND Writing Consulting
Consulting for an Investigational New Drug Application
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Post-authorization Safety Studies
Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects and ensure that the benefits of the medication continue to outweigh its risks.
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Clinical Development Planning
Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
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Period Benefit Risk Evaluation Report (PBRER)
Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
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Medical Labeling
Design and create medical labels that accurately reflect purpose, precautions and other information.
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Periodic Safety Update Report (PSUR)
Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report