Nicopliance, Inc.
Legal Services - Irvine, California, United States
Nicopliance, Inc. Employees
Nicopliance, Inc. Details
Nicopliance, Inc. is dedicated to facilitating Premarket Tobacco Applications with the US Food and Drug Administration and European tobacco product notifications with the European Commission. We are a unique team of experts with more than 25 years experience in Regulatory Science, compliance and quality assurance, developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of ENDS products. We provide complete toxicological risk assessment, product analysis and analytical testing, stability / leachable testing, environmental assessment, and quality management system support. Toxicological Database: Nicopliance has dedicated a team of toxicologists to develop the most comprehensive toxicological database available and dedicated to the vaping industry. TRENDS is a definitive toxicological database with supplemental information pertinent to both the vaping industry and the health community. This technical data is needed to assess the toxicological health effects of ENDS products, including e-liquids. The database currently includes nearly 5000 chemicals commonly found in e-liquids and the aerosol emissions. Toxicological Risk Assessment with iSAT Technology TRENDS with iSAT's intelligent computational modeling algorithm, powered by Gegahelix, provides a complete toxicological risk assessment report based on your specific e-liquid formulation. This unique and more accurate representation of toxicity data is a critical factor to the success of the PMTA approval process, and key to the timely issuance of a Marketing Order by the FDA. Our services include: EU TPD Notifications PMTA Strategy Planning and Submissions Product Testing and Validation Toxicological Risk Assessment Pre-Approval Inspection Support Co-packer and Critical Supplier Audits Quality Management System Implementation Regulatory Surveillance Post-Market Surveillance Programs Reporting Suspected Adverse Effects
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