プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Anurag S.に依頼

India

Pharmaceutical Formulation Development | Technology Transfer | Process Scale-Up | Regulatory Documentation Expert

プロフィール概要

I am a pharmaceutical scientist with over 15 years of experience in formulation development, technology transfer, and process scale-up for oral solid, Oral Liquids, topical, and parenteral dosage forms. I support pharmaceutical, biotech, and CMO/CDMO companies in developing robust formulations, optimizing manufacturing processes, and preparing regulatory documentation that complies with international standards (USFDA, EMA, ROW & WHO). My expertise lies in bridging the gap between R&D and commercial production — ensuring that formulations are scalable, stable, and regulatory compliant. I also assist clients with troubleshooting manufacturing challenges and designing QbD-based development strategies. Key Focus Areas: Formulation development and optimization (tablets, capsules, liquids, ointments, injectables) Process development, scale-up, and validation Technology transfer from R&D to commercial site Quality by Design (QbD) and risk assessment Analytical method and stability study planning Preparation of technical documents (MFR, BMR, PVP, validation reports, CTD/eCTD modules) Regulatory support for ANDA/Dossier submissions I’ve worked with generic pharma manufacturers, CMOs, startups, and nutraceutical brands across US, Europe, India, Europe, International markets and SE Asia. My goal is to help clients accelerate development timelines, ensure manufacturing success, and deliver market-ready formulations. Core Competencies Formulation R&D (Solid Oral, Liquid orals , Topical, Injectable) Technology Transfer & Scale-Up Pre-formulation & Compatibility Studies Stability Studies (Accelerated & Long-Term) Manufacturing Support (MFR, BMR, BPR) Process Validation (PV, CV) Quality by Design (QbD) Analytical Method Development Regulatory Documentation (CTD/eCTD, Validation Reports) Troubleshooting Batch Failures GMP / GLP Compliance Process Optimization & DOE Technical Expertise Oral Solid Dosage Forms (Immediate, Sustained, and Modified Release) Semi-solids (Ointments, Creams, Gels) Oral Liquids & Suspensions Parenteral Formulations Nutraceuticals & Herbal Formulations Packaging Material Selection Impurity Profiling & Risk Analysis Software / Tools Familiar With MS Office (Word, Excel, PowerPoint) Design of Experiments (DOE) – Minitab / JMP QbD-based tools for development planning Stability Data Analysis tools eCTD Documentation Templates Services Offered 🧪 Formulation Development Consulting – Complete product development guidance from concept to prototype. ⚙️ Technology Transfer Support – Document preparation (TTD, MFR, BMR), process mapping, validation support. 📈 Process Scale-Up & Optimization – Support for lab → pilot → commercial scale-up. 📚 Regulatory & Technical Documentation – Dossiers, CTD/eCTD module writing, process validation reports. 🧾 Stability & Analytical Study Design – Protocols and data interpretation. 🔍 Troubleshooting & Root Cause Analysis – Batch failure or process deviation investigation. 💼 Virtual Consulting for Startups – End-to-end support for formulation outsourcing, CMO selection, and tech evaluation. Industries Served Pharmaceuticals (Generics & Branded) Biopharmaceuticals Nutraceuticals & Herbal Products CDMOs / CMOs Academic & Industrial Research Labs Regulatory Consultancy Firms

専門分野

• ★ Drug Development
• ★ Pharmaceutical Regulatory Affairs
• ★ Pharmaceutical Process Development
• ☆ Analytical Chemistry
• ☆ Deformulation
• ☆ Industrial Engineering
• ☆ Pharmaceutical Sciences
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Formulation
• ☆ Drug Substance Characterization
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ Antibiotic Development
• ☆ Bioavailability
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Small Molecule Manufacturing
• ☆ Clinical Trials
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Regulatory Affairs
• ☆ Psychoactive Drugs
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Clinical Study Reports
• ☆ Medical Content Writing
• ☆ Technical & Scientific Writing
• ☆ Science Communication
• ☆ Formulation
• ☆ Nutraceuticals
• ☆ Six Sigma

サービス

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

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Creative Writing, General Proofreading & Editing

Research Market Research, User Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis, Big Data Analytics

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

職務経験

Product Development Group Leader

Torrent Pharmaceuticals Ltd

7月 2024 - 現在

Assistant Manager/Manager

Thame Laboratories

7月 2017 - 6月 2024

Team Leader

Amneal Pharmaceuticals

5月 2015 - 6月 2017

Research Scientist

Alembic Pharmaceuticals

4月 2012 - 5月 2015

学歴

PHD in Pharmaceutical Science

Gujarat Technological University

6月 2012 - 8月 2015

認定資格

• Certified Six Sigma Yellow Belt

  Board of Regents of the university system of georgia

  https://www.coursera.org/account/accomplishments/specialization/certificate/QHN9Z5NEBXD3

  2月 2022 - 5月 2022