Skills & Services
I have a variety of clients, and my work includes:
- Helping marketing teams with technical terminology
- Helping to prepare reports and CTD sections for regulatory submissions
- Preparing quality management audit and operations templates
- Responding to regulatory intelligence requests
- Reviewing medical affairs slide decks
- Verifying regulatory and scientific information already in possession by my clients
- Writing white papers for my clients
- Preparing education and creative content
From 2010 to 2018, my compliance-related roles were in the pharmaceutical and medical device sectors (including diagnostics). These sectors focus on human and animal health. My experience transfers to environment-related sectors (e.g., AgBiotech), including agriculture and food production. My GCP, GMP, and ISO work gives me an understanding of compliance. ICH is important to human health, and VICH is important to animal health. One Health addresses animal-human-environment interface health threats.
Some environmental subjects I relate to are:
- Agriculture
- Animal Health
- Antimicrobial resistance
- Crop spoilage
- Environmental health
- Food production
- Gene pools
- Global regulations, compliance, and quality management
- GMO crops (e.g., introducing genes for microbial-resistant and salt-tolerant crops)
- Grassland management
- One Health
- Zoonoses