I offer a quality medical writing and editing service for the pharmaceutical industry, specialising in producing documents in CTD format for regulatory submission including:
• Clinical Study Reports (Phases I to IV)
• Expert Reports/Clinical Overviews
• Integrated Summaries of Safety and Efficacy
• Investigator's Brochures
• Patient Information Leaflets
• Summaries of Product Characteristics
• Product Packaging and Labelling texts
• Product Monographs
• Periodic Safety Update Reports
• Advisory Board proceedings
• Educational/Marketing materials
• Papers for publication in Journals.
I have 25 years of relevant experience comprising:
• Five years working as a Medical Writer for major international pharmaceutical companies
• Twelve years working freelance including:
• Three years working as a Regulatory Affairs Consultant for GlaxoSmithKline
• One year working as a Regulatory Affairs Consultant for Bristol-Myers Squibb Pharmaceuticals
• One year working in the Corporate Communications Team at SmithKline Beecham
• Three years working for the Medicines and Healthcare Products Regulatory Agency
• Five years working in a research laboratory at the London Hospital Medical College, where I developed assay methods for pharmaceuticals.
telephone: +44(0)1406 370 593
All therapeutic areas covered. Experienced in the following specialist areas:
• CNS - particularly Parkinson's disease
• Oncology - including vaccines
• Cardiovascular - particularly hypercholesterolaemia
• Smoking control
• Women's health
• Antispasticity drugs
• Overactive bladder syndrome
• Multiple sclerosis (NICE documents)
• Wound Management products.
I have presented and published my own research.
• Upper Second Class B.Sc. Honours Degree in Pharmacology from the Welsh National School of Medicine/University College Cardiff
• Member of the European Medical Writers Association (EMWA)
• Member of The Organisation for Professionals in Regulatory Affairs (TOPRA)
• Founder Member of the European Wound Management Association (EWMA)
Editing and Quality Control
I also offer a document editing and Quality Control service. I have a well-equipped home office and I am also able to work on site.