Profile Details

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Hire Likhit M.

India

USD 8 /hr

Senior Regulatory & Analytical Writing Expert | PhD Scholar | 13+ Years in Ophthalmic & Injectable Pharma R&D

Profile Summary

I am a pharmaceutical scientist with 13+ years of experience in analytical R&D, regulatory documentation, and complex generics—including ophthalmics, liposomal/microsphere injectables, and inhalation products. I hold a Master's in Pharmacy and am currently pursuing a PhD focused on bio-waiver-based analytical approaches for ophthalmic suspensions. My expertise spans analytical method development and validation, regulatory submissions (CTD/eCTD Modules 3.2.S & 3.2.P), IVRT, particle size distribution, impurity profiling, and USP-IV dissolution studies. I have successfully led analytical method transfers to multiple CROs/CDMOs and contributed to regulatory dossier preparation for the USFDA, MHRA, and other markets. I’ve authored peer-reviewed publications and specialize in creating high-quality regulatory documentation aligned with ICH, USFDA, and EMA guidelines. I bring both technical depth and regulatory clarity to every project.

Subject Matter Expertise

• ☆ Analytical Chemistry
• ☆ Particle Size Distribution
• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Business Analytics
• ☆ Pharmacy
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Drug Substance Characterization
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Antibiotic Development
• ☆ Pharmaceutical Management
• ☆ Product Evaluation
• ☆ Reverse Engineering
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Medical Writing
• ☆ Formulation
• ☆ Pharmaceutical Formulation
• ☆ Six Sigma

Services

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

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Creative Writing

Research Market Research, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis, Image Processing, Image Analysis, Algorithm Design-Non ML, Algorithm Design-ML, Data Visualization, Text Mining & Analytics, Data Mining

Product Development Formulation, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Reverse Engineering

Work Experience

Research Scholar

Koneru Lakshmaiah Education Foundation

April 2023 - Present

Manager (Team Lead)

Hetero Pharma Ltd.

January 2022 - Present

Deputy Manager

Aurobindo Pharma Ltd

October 2017 - December 2021

Senior Executive Research and Development

Alembic Pharmaceuticals Ltd

September 2016 - October 2017

REGULATORY SCIENTIST

Sun Pharmaceutical Industries R&D Centre

February 2014 - September 2016

Education

Doctor of Philosophy (Ph.D), Pursuing

KONERU LAKSHMAIAH EDUCATION FOUNDATION

April 2022 - Present

MASTER OF PHARMACY (Pharmaceutical Chemistry)

West Bengal University Of Technology

July 2009 - August 2011

Certifications

• Six Sigma Black belt with business Analytics

  Indian Statistical institute (SQC & OR UNIT, HYDERABAD)

  May 2025 - Present

Publications

JOURNAL ARTICLE

Likhit Mandal, Jayaraman Vinayagam, Rahul L. Gajbhiye, Meyyappan Arumugam, Anushree Achari, Parasuraman Jaisankar (2017). Substituted furans as potent lipoxygenase inhibitors: Synthesis, in vitro and molecular docking studies . Bioorganic Chemistry.