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USD 11 /hr

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Hire Khushbu P.

India

USD 11 /hr

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

Profile Summary

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)

Subject Matter Expertise

Services

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

Work Experience

Freelancer

Pharmalex

September 2020 - Present

Freelancer

Gegahelix

July 2020 - September 2020

Regulatory executive

Gowrie Research Pvt Ltd.

April 2016 - February 2020

Education

Master of pharmacy (Pharmacology)

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

May 2013 - May 2015

Bachelor of pharmacy

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

May 2010 - May 2013

Diploma in pharmacy

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

May 2008 - May 2010

Certifications

Certification details not provided.

Publications

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