Profile Details

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Hire Neil M.

United Kingdom

USD 150 /hr

GMP & Validation Specialist, Analytical Method Development, Regulatory & Technical Documentation Expert

Profile Summary

I’m a scientific consultant specialising in GMP‑compliant documentation, analytical method development, validation, and regulatory support for pharmaceutical and veterinary‑medicinal manufacturers. With over 35 years of hands‑on experience in laboratory operations, quality systems, and technical leadership, I help organisations produce clear, defensible, audit‑ready documentation that stands up to regulatory scrutiny. My work spans the full lifecycle of analytical and manufacturing processes — from method development and optimisation, through validation and transfer, to the creation of high‑quality reports, protocols, and regulatory submissions. I’m particularly skilled at translating complex scientific data into precise, structured, and compliant documentation that regulators, auditors, and clients can trust. Clients come to me when they need: - Analytical method development, troubleshooting, and optimisation - Method validation and transfer (ICH, VICH, GMP) - Technical and regulatory documentation (protocols, reports, SOPs, dossiers) - Expert scientific review and interpretation - Clear, concise writing that communicates technical detail without ambiguity I combine scientific rigour with a practical, collaborative approach — helping teams solve problems, meet deadlines, and strengthen their quality systems with confidence. Whether you need a single expert report or end‑to‑end support for a validation programme, I bring accuracy, clarity, and reliability to every project.

Subject Matter Expertise

• ★ Liquid Chromatography/HPLC
• ☆ Analytical Chemistry
• ☆ Gas Chromatography
• ☆ Information Retrieval
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Gap Analysis

Services

• Writing
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing, Audio Transcription, General Proofreading & Editing

Consulting Scientific and Technical Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Validation, Quality Assurance & Control (QA/QC)

Work Experience

Head of Analytical and Operational Services

Kinclaven Formulaton, Analytical and Reguratory Services

November 2023 - Present

Freelance Consultant

Neil Melville

December 2017 - October 2023

Senior Analyst

Elanco

January 2008 - December 2016

Analytical Supervisor

Novartis Animal Health

November 2005 - January 2008

Analytical Development Chemist

Novartis Animal Health

November 1997 - November 2005

Stability Technician

Grampian Pharmaceuticals

November 1995 - November 1997

Quality Control Technicial

Grampian Pharmaceuticals

May 1987 - November 1995

Education

ONC Chemistry

Fife College

September 1987 - May 1989

Certifications

• Analytical Methods Validation for FDA Compliance

  The Center for Professional Advancement

  January 2026 - Present

• Drug Product Stability and Shelf-Life

  The Center for Professional Advancement

  January 2026 - Present

• Business Writing Skills

  High speed training

  January 2026 - Present

• Member of the Royal Society of Chemistry

  Royal Society of Chemistry

  August 2001 - Present