プロフィール詳細

プロジェクトを作成

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Neil M.に依頼

United Kingdom

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

プロフィール概要

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.

専門分野

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

サービス

• 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)

職務経験

Head of Analytical and Operational Services

Kinclaven Formulaton, Analytical and Reguratory Services

11月 2023 - 現在

Freelance Consultant

Neil Melville

12月 2017 - 10月 2023

Senior Analyst

Elanco

1月 2008 - 12月 2016

Analytical Supervisor

Novartis Animal Health

11月 2005 - 1月 2008

Analytical Development Chemist

Novartis Animal Health

11月 1997 - 11月 2005

Stability Technician

Grampian Pharmaceuticals

11月 1995 - 11月 1997

Quality Control Technicial

Grampian Pharmaceuticals

5月 1987 - 11月 1995

学歴

ONC Chemistry

Fife College

9月 1987 - 5月 1989

認定資格

• Analytical Methods Validation for FDA Compliance

  The Center for Professional Advancement

  1月 2026 - 現在

• Drug Product Stability and Shelf-Life

  The Center for Professional Advancement

  1月 2026 - 現在

• Business Writing Skills

  High speed training

  1月 2026 - 現在

• Member of the Royal Society of Chemistry

  Royal Society of Chemistry

  8月 2001 - 現在