Erika Porcelli

Pardot MailChimp SPF Microsoft Office 365 SharpSpring Salesforce

ind nda & anda submissions 510 pma & de novo submissions outsourced quality ra qs implementation and or remediation technical file dhf remediation regulatory action response remediation m a due diligence 3rd party gmp expert business consulting & services medical device regulatory compliance quality assurance pharmaceutical biologics change management iso 13485 fda mdr product life cycle management new product approval post-approval support regulatory affairs audits & assessments cybersecurity in medical devices data integrity cgmp consulting outsourced quality support strategic consulting manufacturing validation remediation services product classification compliance training inspection readiness design history file regulatory response 21 cfr part 11 mdsap laboratory testing expert witness services combination products compounding pharmacies post-market surveillance capa support root cause investigation adverse event reporting recall management submission preparation 510(k) pma submissions clinical reviews product lifecycle accelerated market entry risk management supply chain security regulatory strategy international submission support device exemptions clinical evaluations management consulting hospital & health care medical b2b