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Profile Details
Contact
★★★★★
☆☆☆☆☆
USD 50 /hr
Hire Dr. Nare Simonyan
Armenia
USD 50 /hr

More than 10 years of experience as Regulatory Affairs Specialist, Medical and Scientific Writer, Clinical Trial Consult

Profile Summary
Subject Matter Expertise
Services
Consulting Technical consulting, Market research, Feasibility study
Product development Formulation & development, Product feedback, Material sourcing, Large-scale manufacturing, Regulatory compliance, Product design
Writing Grant proposal, Journal article, Review article, Blog article, News article, Regulatory documents, Clinical trial documents, Marketing content, Educational content
Data science & analysis Statistical analysis
Research Internet research, Systematic reviews and meta-analysis, Review article, Evidence-based answers, Secondary data compilation, Statistical review of research data, Literature search
Work Experience

RA specialist

FMD Services LP

January 2018 - Present

Education

PhD in Pharmacy

Yerevan State University, Yerevan, Armenia Faculty of Chemistry

September 2006 - September 2011

Certifications
  • Proposal Writing

    NonprofitReady

    December 2021 - Present

  • Becoming a Great Leeder - Leadership skills

    NonprofitReady

    November 2021 - Present

  • Promotional Submissions in eCTD format: Grouped Submissions

    US FDA

    August 2021 - Present

  • Generic Drug Science and Research Initiatives Public Workshop

    US FDA CDER

    June 2021 - Present

  • FDA and Health Canada Regional ICH Consultation Webinar

    US FDA CDER

    May 2021 - Present

  • FDA Study Data Technical Rejection Criteria (TRC): What you need to know.

    US FDA CDER

    May 2021 - Present

  • ICH Guidelines for Good Clinical Practice

    FMD KL EUROPE

    January 2020 - Present

  • Labeling and product Information (SmPC, PIL, USPI, CCDS)

    FMD KL EUROPE

    February 2019 - Present

  • Post Approval Manufacturing Changes

    FMD KL EUROPE

    January 2019 - Present

  • Drug Master Files (DMF) and Active Drug Master Files (ASMF)

    FMD KL EUROPE

    January 2019 - Present

  • Specifications and Justification of Specifications

    FMD KL EUROPE

    January 2019 - Present

  • Good Manufacturing Practices (GMP) for Investigational Products

    FMD KL EUROPE

    January 2019 - Present

  • CTD Dossier Introduction, types of applications for regulated products

    FMD KL EUROPE

    January 2019 - Present

  • CMC General Regulatory Topics

    FMD KL EUROPE

    January 2018 - Present

  • Introduction to Drug Discovery and Development

    FMD KL EUROPE

    January 2018 - Present

  • Change Management/Change Control

    FMD KL EUROPE

    January 2018 - Present

  • EU Guidelines for Good Manufacturing Practice for Medicinal Products

    USAID EDMC

    February 2013 - Present

  • Pharmaceutical Summer School

    USAID CAPS

    July 2010 - Present

Publications
WEBSITE
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