Matt Longhurst

Outlook Blue Host Microsoft Office 365 Amazon AWS Mobile Friendly Hotjar Linkedin Marketing Solutions Wix Google Tag Manager Varnish

medical device regulatory submissions eu mdr consulting medical writing cmc regulatory technical quality services ectd publishing eu ivdr consulting biologics small molecules ind authoring bla authoring fda drug & device regulatory submissions combination devices clinical trial documents patient narratives clinical evaluation reports 510 & pmas performance evaluation documentation biotechnology research regulatory writing eu mdr in-vitro diagnostics technical consulting quality consulting clinical regulatory strategy submission management post-market surveillance pmcf plans patient safety narratives regulatory consulting strategic writing quality management systems drug master files agency interactions technical documentation regulatory submissions medical devices combination products regulatory strategy training & education project management health authority compliance ai in regulatory writing clinical trial support risk management plans regulatory advocacy technical editing document publishing custom training solutions certified good clinical practice medical device compliance regulatory guidelines device performance evaluation healthcare compliance clinical development strategy pediatric study plans quality assurance continuous compliance support scientific narrative development workflow optimization agile project management hospital & health care productivity