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ToxWriters
@vishnujatoth
MS Pharma Regulatory Toxicologist with ERT certification
Inde
À propos de moi
I am a toxicologist by education and profession with 7 years of experience in toxicological risk assessment for chemical and pharmaceutical drugs, and for medical devise E&L.
I will help you with:
EMA Environmental risk assessment for medicinal product (ERA)
PDE report
OEL Report
SDS creation for North America, Europe and Australia and newzealand.
Medical device toxicology risk assessment
BEP & BER preparation
Study monitoring
CTD module 2.4 , 2.6 and module 4 preparation
www.toxwriters.com
Info@toxwriters.com
ToxWriters
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Rédaction technique
I will provide toxicological risk assessment, pde, oel, ctd, nco, ti, te, mos
Rédaction technique
I will provide regulatory medical writing services ind, nda, maa, anda, and 505b2
Expérience professionnelle
Toxicologist
Toxwriter • Indépendant
Jun 2018 - Present • 8 yrs 3 mos
I play a key role in occupational and regulatory toxicology, supporting global compliance and risk assessment initiatives: Conduct Permitted Daily Exposure (PDE) derivations, Occupational Exposure Limit (OEL) setting, and Occupational Exposure Band (OEB) assignment for APIs, intermediates, and impurities. Perform toxicological qualification of impurities, including nitrosamines, using structure–activity relationship (SAR) analysis and ICH M7/Q3A/Q3B guidance. Carry out Environmental Risk Assessments (ERA) for human medicinal products in accordance with EMA and OECD guidelines, including Phase I/II assessments, PEC/PNEC calculations, and PBT/vPvB evaluations. Prepare and review Safety Data Sheets (SDS) as per global GHS, OSHA, and REACH standards. Author Modules 2.4 and 2.6 of the Common Technical Document (CTD) for regulatory submissions. Support industrial hygiene programs through hazard identification, exposure assessments, and recommending controls to mitigate occupational health risks.
11 Avis
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javaancosmetics
Royaume-Uni
Réponse du freelance
Utile?
ludvigs2020
Suède
Collaboration en cours
Utile?
ludvigs2020
Suède
Collaboration en cours
Quick draft of PDE report. Open to feedback. I asked Vishnu to include more sources/references and also add some text about some topics which were not in the first draft. Difficult to give fair feedback on quality since I am not as competent in the field as Vishnu. If the recipients of the PDE report...
Réponse du freelance
Utile?
mikekratos
Royaume-Uni
Vishnu was very helpful and communicated effectively throughout the process. He asked relevant questions and produced a high quality piece of work that matched the brief well. I'd highly recommend him to anyone looking for a high quality toxicology report.
Réponse du freelance
Utile?
mikegolden1
Australie
although i got some answers. There was no face to face and i feel like some of my quesitions probably were just googled. But probably my fault for not adding more questions.
Utile?
