Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 35 /hr

★★★★★

☆☆☆☆☆

Hire Anand K.

India

USD 35 /hr

Freelance Regulatory Affairs Services for Pharma industry of both Formulation and API

Profile Summary

Regulatory Affairs Services like ANDA, ANDS, Pre-IND, Control Correspondence, DMF, APIMF, CEP, and Dossier (Rest of World).

Subject Matter Expertise

• ★ Gap Analysis
• ★ Regulatory Writing
• ★ CMC Documentation
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Microbiology Testing
• ☆ Solid Form Screening
• ☆ Drug Stability Testing
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Product Evaluation
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Packaging Design
• ☆ Software Development
• ☆ Software QA & Testing
• ☆ Mobile Application Development
• ☆ Desktop Application Development
• ☆ Web Application Development
• ☆ Cloud Application Development
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Spec Sheets
• ☆ Textbook Content Writing
• ☆ Language Translation
• ☆ Audio Transcription
• ☆ Formulation
• ☆ Cosmetic Formulation
• ☆ Pharmaceutical Formulation
• ☆ Cosmetic & Personal Care Product Manufacturing
• ☆ Herbal Products
• ☆ Nutraceuticals
• ☆ Supplements
• ☆ Essential Oils
• ☆ Consumer Products
• ☆ Project Management

Services

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing, Copywriting, Audio Transcription

Research Gap Analysis, Scientific and Technical Research

Consulting Business Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing

Work Experience

Sr. Manager Regulatory Affairs (Formulation and API)

celltrion Inc

May 2015 - December 2021

Education

Master in Pharmacy

Rajiv Gandhi University of Health Sciences

August 2003 - August 2005

Certifications

• Excellence in Execution for the execution of AntiViral Tablets Exhibit batches in very short time for USA market.

  Dr Reddy's Labs

  September 2007 - Present