プロフィール詳細

プロジェクトを作成

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Likhit M.に依頼

India

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

プロフィール概要

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.

専門分野

• ☆ 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

サービス

• 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

職務経験

Research Scholar

Koneru Lakshmaiah Education Foundation

4月 2023 - 現在

Manager (Team Lead)

Hetero Pharma Ltd.

1月 2022 - 現在

Deputy Manager

Aurobindo Pharma Ltd

10月 2017 - 12月 2021

Senior Executive Research and Development

Alembic Pharmaceuticals Ltd

9月 2016 - 10月 2017

REGULATORY SCIENTIST

Sun Pharmaceutical Industries R&D Centre

2月 2014 - 9月 2016

学歴

Doctor of Philosophy (Ph.D), Pursuing

KONERU LAKSHMAIAH EDUCATION FOUNDATION

4月 2022 - 現在

MASTER OF PHARMACY (Pharmaceutical Chemistry)

West Bengal University Of Technology

7月 2009 - 8月 2011

認定資格

• Six Sigma Black belt with business Analytics

  Indian Statistical institute (SQC & OR UNIT, HYDERABAD)

  5月 2025 - 現在

出版物

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.