Ekrity

I worked in quality management departments for about 8 years - at an interface between regulatory affairs and various departmental operations. I have been a freelance biotechnology consultant and writer since 2018. My support helps validate regulatory and scientific information and condenses large amounts of technical information into easier-to-digest reports. Bridging gaps between industry and life science is what I do. By strengthening arguments, I help get products into marketplaces. Familiar subjects to me include: Writing, biotechnology, regulation, quality, compliance, science, biological and chemical molecules, and global product value chains. My life science education includes: - PhD in molecular microbiology (genes and proteins) - MSc in pharmaceutical manufacturing technology (EU Qualified Person course) - BSc in animal biology - HND in horse studies from an agricultural college. 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 I can translate intricate scientific information into clear, concise narratives. My expertise allows my clients to have quicker comprehension and enhances the effectiveness of compliance. From my drafting of reports to preparing content for submissions, my clients navigate the regulatory landscape with clarity and confidence. My pharmaceutical and medical device sector work includes diagnostics, and focuses on human and animal health. My experience transfers to agriculture-related sectors including food production and environmental health.