Regulatory & Clinical Writing
Services
We Can Help You
Pharmaceutical
Clinical Study Protocols
Clinical Study Reports (CSR)
Informed Consent Forms
Patient Narratives
Investigator Brochures
CTD Module 2 Summaries for Food and Drug Administration (FDA) and European Medicines Agency (EMA) submissions
Integrated Summaries of Safety (ISS)
Integrated Summaries of Efficacy (ISE)
Experienced working on components of New Drug Appplications (NDA),Investigational New Drugs (IND), Biologics License Applications (BLA) and Marketing Authorisation Application (MAA)
Health Authority Questions
Briefing Documents
Device
Clinical Investigational Plans
Clinical Investigational Reports
Clinical Evaluation Reports
Lay Summaries
Editing
Scientific peer review
Editing
Peer Review
Formatting
Quality Checks
Preparation of Standard Operating Procedures (SOP)
Work Instructions & Guidelines
Training & Mentoring
Writing for Human Medicine and Veterinary Medicine
TESTIMONIAL
I have had the pleasure to work with Rebecca for over 10 years while she was leading the Medical Writing Department at a Clinical Research Organisation. Rebecca understands the meaning and importance of timelines to her clients. At critical times, she is able to integrate herself within a sponsor team where her combined medical writing expertise and clinical research experience are valued. Rebecca is professional and proactive with high expectations of her work and leads by example.
Senior Management, CRO
Tel: +44 (0) 7985 417069 or (0) 7480 497573
Email: Rebecca.Farrar@Iatrikemedicalwriting.com
www.Iatrikemedicalwriting.com
