Darshan Dave

Darshan Dave Email and Phone Number

Freelance Consultant for Clinical Development and Regulatory Medical Writing @ Self-employed
Ahmedabad, GJ, IN
Darshan Dave's Location
Greater Ahmedabad Area, India
About Darshan Dave

A Certified Pharmacist & Clinical Research Professional having 14+ years of hands-on industry experience and possess following skills which helps life science innovators to grow faster.1. Technical skills- Clinical Development, Clinical Study Outsourcing, Regulatory Medical Writing, Project Management, GCP Monitoring & Auditing, Quality & Regulatory Compliance.2. Leadership skills- Resource (Skilled Professional, Budget, Timelines & Quality) Management, Critical Thinking, Conflict Resolution, Problem Solving, Effective Communication, Being Proactive, strategic approach, etc.3. Business Skills- RFx Preparation, Prospect presentations, Budgeting, Negotiations, Bid Defense, Contracting, Project Health Update, Client Management, Risk Analysis, etc.

Darshan Dave's Current Company Details
Self-employed

Self-Employed

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Freelance Consultant for Clinical Development and Regulatory Medical Writing
Ahmedabad, GJ, IN
Darshan Dave Work Experience Details
  • Self-Employed
    Freelance Consultant For Clinical Development And Regulatory Medical Writing
    Self-Employed
    Ahmedabad, Gj, In
  • Basilion
    Clinical Development Consultant & Regulatory Medical Writer
    Basilion Feb 2019 - Present
    India
    Currently, I am working as “Independent Consultant” and heling life science innovators globally into their product development journey i.e. IND, NDA, BLA, ANDA & 505(B2) submissions through following consulting services.1. Clinical Development - Clinical Study Design, Regulatory & Feasibility Assessment, CRO Outsourcing- Qualification, Negotiations, Contracting and End to End Project Management (timeline, resource & quality). 2. Regulatory Medical Writing – a. Clinical Study Documents - Clinical Study Protocol (CSP), Investigator Brochure (IB), Informed Consent Form (ICF), Case Report Form (CRF), Clinical Study Report (CSR), Patient Narratives) etc. b. Aggregate Report Writing - Periodic Safety Updated Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Updated Report (DSUR), Risk Management Plan (RMP) etc.c. Marketing Authorization Application (MAA) - eCTD (Module 2.4 to 2.7 preparation), Summary of Product Characteristics (SmPC), Product Information Leaflets (PIL), Product Monograph (PI) etc.d. Regulatory Affairs- Briefing Books, Regulatory Advice, Scientific Advise, Query Responses. 3. Clinical Study Monitoring & Auditing - GCP Monitoring & Auditing- Onsite/Remote (100% SDV).4. Independent Audit of CRO/ Clinical Trial Sites/ Vendor - Quality Management System (QMS) audit according to global regulatory standards.
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  • Biorasi
    Senior Medical Writer
    Biorasi Sep 2022 - Apr 2024
    United States
    View
  • Veeda Clinical Research Limited
    Associate Scientist - Biopharmaceutics & Project Management
    Veeda Clinical Research Limited Jul 2016 - Feb 2019
    Ahmedabad, Gujarat, India
    View
  • Zydus Research Centre
    Senior Scientific Assistant- Clinical Research
    Zydus Research Centre Jun 2012 - Jul 2016
    India
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  • Shah Multi Specialty Hospital
    Clinical Research Coordinator
    Shah Multi Specialty Hospital Aug 2011 - Jun 2012
    Ahmedabad, Gujarat, India
  • Torrent Pharmaceuticals Ltd
    Research Trainee
    Torrent Pharmaceuticals Ltd Sep 2010 - Jul 2011
    Ahmedabad, Gujarat, India
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  • Elite Pharmaceutical
    Production Trainee
    Elite Pharmaceutical Jun 2009 - Aug 2009
    Ahmedabad, Gujarat, India
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  • Naman Medical Store
    Pharmacy Manager
    Naman Medical Store Aug 2005 - Apr 2009
    Ahmedabad, Gujarat, India
  • Sheth Vadilal Sarabhai General Hospital And Sheth School Of Nursing
    Hospital Pharmacist
    Sheth Vadilal Sarabhai General Hospital And Sheth School Of Nursing May 2005 - Aug 2005
    Ahmedabad, Gujarat, India
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Darshan Dave Education Details

Frequently Asked Questions about Darshan Dave

What company does Darshan Dave work for?

Darshan Dave works for Self-Employed

What is Darshan Dave's role at the current company?

Darshan Dave's current role is Freelance Consultant for Clinical Development and Regulatory Medical Writing.

What schools did Darshan Dave attend?

Darshan Dave attended Gujarat Technological University (Gtu).

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