Arianna Sylvester

Account Manager @Vi-Leon

Boston, MA, US

As an Account Manager for Vi-Leon’s Life Sciences Division, I’m focused on providing consultants who have experience deploying solutions across all Pharmaceutical & Medical Device disciplines. Our specialized network of consultants focus on project work such as Warning Letter Remediation, EU MDR, IVDR, Quality System Implementation/ Upgrades, Technology Transfers, and New Product Introductions. Below is a list of skill sets we focus in:Regulatory Affairs:510K\'s | PMA\'s | NDA\'s | BLA\'s | IND\'s | IDE\'s | CMC | Regulatory Strategy | International Regulatory | CER writing | etc.Validation/Engineering:Equipment Validation | Cleaning Validation | Process Validation | Test Method Validation | Computer Systems Validation | Facilities Validation | Mechanical Engineering | Sterilization | etc.Quality:Quality Engineering | Quality Systems | Quality Assurance | Quality Control | CAPA\'s | Investigations | Risk Management | Design Quality | Investigations | Deviations | Batch Record Review | etc.