Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 30 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Harsh V.

India

USD 30 /hr

Medical/Scientific/Regulatory/Newsletter/CMC/Dossier/Research/Review/Thesis/Protocol/Report/Article writing & editing.

Profile Summary

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experience: Responsible for support and delivery of Regulatory information solutions globally across the Pharmaceuticals, Biologics & Medical devices companies for their Corporate and R&D units. Involved in preparation and review of Scientific/Medical/Newsletters writing, Data/Text mining, Market & Deals comparison, Medicines/Health agencies monitoring, Preclinical, Clinical, Post-authorization, CMC authoring and Pharmacovigilance monitoring for pharmaceutical products and medical devices. Involved in preparation and review of the Project agreement, SOW, SOP, POC, Project charter, COGs, Research report based on customer meeting & understanding of the requirements for successful delivery. Skills: Pharmaceuticals research & development; Scientific/ Medical/ Newsletters writing; Data mining/ monitoring & migration; Regulatory queries, Market complaints & Post-approval variations/changes; Dossier & CMC technical documents preparation & review; Pharmacovigilance & Clinical research; Technology transfer & Gap analysis; Pharma research & Regulatory insight landscape; Product life cycle management & IP support; Data & analytics services; Market competitive & deals intelligence Lean, six sigma & QbD tools. Software Handled: ePublishing, BulletinPro, Cortellis, TransPerfect, ELN, WebSite-Watcher, Lorenz docuBridge, PAS/X, SAP, Minitab17, DOCHUB, Design Expert10, MODDEPro12, LeanQbD, Kinetica5, GastroPlus9, WinNonlin, Graph Pad Prism5, Chem Draw7, Origin Pro8 and End Note6. Research Publications: Published more than 17 research articles (Approx. 79 Impact factors) and attended 12 international conferences; for details, please follow the link:- Research Gate: https://www.researchgate.net/profile/Harsh-Vardhan-8 Google Scholar: https://scholar.google.com/citations?user=BedQ8lAAAAAJ&hl=en&authuser=1

Subject Matter Expertise

• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Copywriting
• ☆ Emails & Newsletters
• ☆ Scientific Proofreading & Editing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting, Newswriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Big Data Analytics, Data Insights

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development, Prototyping

Work Experience

Research & Review Writer

Self employed

January 2022 - Present

Dr. Reddy's Laboratories (India)

December 2017 - Present

Specialist

Dr. Reddys Lab

January 2017 - January 2022

Scientists

IIT (BHU)

January 2013 - January 2017

Education

PhD

IIT (BHU), Varanasi, India

January 2013 - January 2017

PhD (Pharmaceutical Science and Technology)

Indian Institute of Technology (BHU) Varanasi

2013 - 2017

Certifications

• M Pharm

  LPU

  January 2010 - January 2012

Publications

JOURNAL ARTICLE

Vinoth, V., Sathiyamurthy, S., Ajay, C.V., Vardhan, H., Siva, R., Prabhakaran, J., Kumar, C.S.(2022). Experimental studies on single point incremental sheet forming of stainless steel 409L alloy . Materials Today: Proceedings. 62. p. 599-605.

Upadhyay, M., Vardhan, H., Mishra, B.(2020). Natural polymers composed mucoadhesive interpenetrating buoyant hydrogel beads of capecitabine: Development, characterization and in vivo scintigraphy . Journal of Drug Delivery Science and Technology. 55.

Mittal, P., Vardhan, H., Ajmal, G., Bonde, G.V., Kapoor, R., Mittal, A., Mishra, B.(2019). Formulation, optimization, hemocompatibility and pharmacokinetic evaluation of PLGA nanoparticles containing paclitaxel . Drug Development and Industrial Pharmacy. 45. (3). p. 365-378.

Upadhyay, M., Adena, S.K.R., Vardhan, H., Yadav, S.K., Mishra, B.(2019). Locust bean gum and sodium alginate based interpenetrating polymeric network microbeads encapsulating Capecitabine: Improved pharmacokinetics, cytotoxicity &in vivo antitumor activity . Materials Science and Engineering C. 104.

Adena, S.K.R., Upadhyay, M., Vardhan, H., Mishra, B.(2019). Gold nanoparticles for sustained antileukemia drug release: Development, optimization and evaluation by quality-by-design approach . Nanomedicine. 14. (7). p. 851-870.

Upadhyay, M., Adena, S.K.R., Vardhan, H., Yadav, S.K., Mishra, B.(2018). Development of biopolymers based interpenetrating polymeric network of capecitabine: A drug delivery vehicle to extend the release of the model drug . International Journal of Biological Macromolecules. 115. p. 907-919.

Vardhan, H., Mittal, P., Adena, S.K.R., Upadhyay, M., Yadav, S.K., Mishra, B.(2018). Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach . International Journal of Biological Macromolecules. 108. p. 729-743.

Upadhyay, M., Adena, S.K.R., Vardhan, H., Pandey, S., Mishra, B.(2018). Development and optimization of locust bean gum and sodium alginate interpenetrating polymeric network of capecitabine . Drug Development and Industrial Pharmacy. 44. (3). p. 511-521.

Adena, S.K.R., Upadhyay, M., Vardhan, H., Mishra, B.(2018). Development, optimization, and in vitro characterization of dasatinib-loaded PEG functionalized chitosan capped gold nanoparticles using Box–Behnken experimental design . Drug Development and Industrial Pharmacy. 44. (3). p. 493-501.

Vardhan, H., Mittal, P., Adena, S.K.R., Upadhyay, M., Mishra, B.(2017). Development of long-circulating docetaxel loaded poly (3-hydroxybutyrate-co-3-hydroxyvalerate) nanoparticles: Optimization, pharmacokinetic, cytotoxicity and in vivo assessments . International Journal of Biological Macromolecules. 103. p. 791-801.

Vardhan, H., Mittal, P., Adena, S.K.R., Mishra, B.(2017). Long-circulating polyhydroxybutyrate-co-hydroxyvalerate nanoparticles for tumor targeted docetaxel delivery: Formulation, optimization and in vitro characterization . European Journal of Pharmaceutical Sciences. 99. p. 85-94.

Yadav, S.K., Khan, G., Bansal, M., Vardhan, H., Mishra, B.(2017). Screening of ionically crosslinked chitosan-tripolyphosphate microspheres using Plackett–Burman factorial design for the treatment of intrapocket infections . Drug Development and Industrial Pharmacy. 43. (11). p. 1801-1816.

Singh, S., Vardhan, H., Kotla, N.G., Maddiboyina, B., Sharma, D., Webster, T.J.(2016). The role of surfactants in the formulation of elastic liposomal gels containing a synthetic opioid analgesic . International Journal of Nanomedicine. 11. p. 1475-1482.

Verghese, M.M., Ram, M.K., Vardhan, H., Malhotra, B.D., Ashraf, S.M.(1997). Electrochromic properties of polycarbazole films . Polymer. 38. (7). p. 1625-1629.

Ram, M.K., Sundaresan, N.S., Vardhan, H., Malhotra, B.D.(1996). Electrochromic response of thin Polypyrrole film in semi-solid electrolyte . Journal of Materials Science Letters. 15. (11). p. 997-1000.

Verghese, M.M., Ram, M.K., Vardhan, H., Ashraf, S.M., Malhotra, B.D.(1996). Polycarbazole-film-coated electrodes as electrochromic devices. Advanced Materials for Optics and Electronics. 6. (5). p. 399-402.