Dr. Sushmita Ganguli

"Transforming Healthcare with Expertise and Empathy"


Regulatory Writing

  • Prescribing Information:  CIPREMI (REMDESIVIR) for Injection and intravenous use (Sample) 

    Prescribing Information:  CIPREMI (REMDESIVIR) for Injection and intravenous use (Sample) 

    Full Prescribing Information: Generic Name Remdesivir Qualitative and Quantitative composition Remdesivir for injection (lyophilized powder), 100 mg: Each single-dose vial of remdesivir for injection,100 mg, contains a sterile, preservative-free white to off-white to yellow lyophilized powder that is to be reconstituted with 19 mL of Sterile Water for Injection and diluted into 0.9% sodium chloride… Continue reading

  • Patient Information Sheet And Informed Consent Form (Sample)

    Patient Information Sheet And Informed Consent Form (Sample)

    Study Title A Multi-Centric, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications  Sponsor Not Applicable Principal Investigator Name: Not ApplicableTelephone: Not ApplicableE-mail: Not Applicable Dear Participant,  We would like to invite you to participate in a pivotal phase 2 study aimed to evaluate… Continue reading

  • Clinical Study Protocol (Sample)

    Clinical Study Protocol (Sample)

    Study Title: The Impact of Covid -19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India. Table of Contents: Background and Introduction Many studies have shown previous infectious diseases epidemics to cause severe long term and persistent psychological consequences. In this fight against Covid 19, healthcare professionals played a significant role and may undergo… Continue reading

Welcome

This blog contains various research, studies, viewpoints and experiences that I have gathered over the decades in the fields of Homeopathy, Medical Writing and Scientific Communications. Feel free to reach out to me if you have any questions/suggestions about the content or need assistance regarding the topics.