プロフィール詳細

プロジェクトを作成

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Khushbu P.に依頼

India

Regulatory affairs (eCTD submission) with 3+ years of experience. Working as freelancer for PharmaLex (PDE compilation)

プロフィール概要

I am Khushbu Pitroda, completed masters in pharmacy (Pharmacology) in 2015, Bachelor of pharmacy in 2013 and Diploma in pharmacy in 2010 from Gujarat technological university (A.R college of pharmacy, vallabh vidya nagar, Anand, Gujarat). Previous research work: Evaluation of cardio-protective effect of averrhoa carambola fruits in isoproterenol induced myocardial infraction in rats. Work experience: - Worked as toxicologist (non-clinical toxicology) at Accuprec Research Labs Pvt Ltd, Ahmadabad. From December 2015 to March 2016. - Toxicity study in rodents and non rodents as per OECD guidelines. - Worked as Regulatory executive at Gowrie Research Pvt Ltd. From April 2016 to Feb 2020. - eCTD submission (Generic application, Hybrid application through National, Decentralize, Mutually recognized procedure) - Module compilation m1, m2 (2.4- non-clinical overview) (2.5 clinical overview) - Regulatory strategy document (RSD) (for EU and US market), qualitative and quantitative (QnQ) data compilation and review - PDE and elemental impurities calculation as per ICH and EMA guidelines. - BE study protocol review - Worked as freelancer for Gegahelix - Premarket Tobacco Product Applications (PMTA) as per FDA guidelines. - Working as freelancer for PharmaLex. - Permitted daily exposure (PDE) and Occupational exposure limit (OEL) calculation as per ICH guidelines. Skills MS office (word, excel, power point)

専門分野

• ★ Regulatory Affairs
• ☆ Preclinical Research
• ☆ Research
• ☆ Regulatory Writing
• ☆ Clinical Trial Protocol Writing
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Science Communication

サービス

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis

職務経験

Freelancer

Pharmalex

9月 2020 - 現在

Freelancer

Gegahelix

7月 2020 - 9月 2020

Regulatory executive

Gowrie Research Pvt Ltd.

4月 2016 - 2月 2020

学歴

Master of pharmacy (Pharmacology)

A.R college of pharmacy, vallabh vidya nagar, anand, gujarat.

5月 2013 - 5月 2015

Bachelor of pharmacy

A.R college of pharmacy, vallabh vidya nagar, anand, gujarat.

5月 2010 - 5月 2013

Diploma in pharmacy

A.R college of pharmacy, vallabh vidya nagar, anand, gujarat

5月 2008 - 5月 2010

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ISSUE

(2016). EVALUATION OF CARDIO PROTECTIVE EFFECT OF AVERRHOA CARAMBOLA FRUIT IN ISOPROTERENOL INDUCED MYOCARDIAL INFARCTION IN RATS . International journal of pharmaceutical sciences and research. 7. (7). International Journal of Pharmaceutical Sciences and Research