Advasur is your trusted partner in DSCSA compliance across the entire supply chain.
Comprehensive Brand Protection and Consulting Services
Experiencing a counterfeiting incident can often highlight the need for a robust brand protection program. Advasur is committed to helping you not only recover from such incidents but also establish strong preventive measures. Our proactive approach ensures that your brand remains secure against future threats.
Advasur offers a wealth of expertise and a comprehensive toolkit to support all aspects of brand protection. Whether you need to refine your strategy, improve operational efficiency, address program gaps, or bolster your internal team, we can help you achieve your goals faster. Our Brand Protection service provides an in-depth assessment to ensure your program’s effectiveness and resilience.
Advasur’s specialists utilize a detailed, risk management-based framework. This framework encompasses all essential capabilities and best practices for a successful brand protection program. We assess your current operations against the framework criteria and develop a customized strategy that aligns with your business objectives and risk profile, ensuring comprehensive protection against illicit trade. By partnering with Advasur, you gain a dedicated ally in safeguarding your brand, enhancing your operations, and securing your supply chain against the ever-evolving threats of counterfeiting and illicit trade.
With Advasur ATP You Can:
- Keep product flowing throughout the supply chain
- Avoid any supply chain disruption
- Provide full compliance with all 10 requirements
- Avoid company crushing fines
- Establish your company SOPs
- Feel assured with Complete Audit Assistance
Cost-effective Validation, Qualification, and Testing Solutions
Whatever FDA product jurisdictional business sector you operate in, our experienced subject matter experts use proven processes and industry best practices to help you comply with all necessary regulations and drive value across your supply chain.
We provide Computer System Validation (CSV) and Programming for:
- Enterprise Resource Planning (ERP).
- Electronic Product Code Information Service (EPCIS).
- Quality Management Systems (QMS).
- Process and Method validation.
- Sterilization validation.
- Cleaning validation.
- Facilities and Utilities qualification.
- Temperature and environmental monitoring.
- Equipment qualification.
- Factory and site acceptance testing.
- Risk assessment and risk mitigation.
- Validation and compliance training.
- Electronic Document Management Systems (EDMS).
- Corrective Action and Preventive Action (CAPA).
- Learning Management Systems (LMS).
- Manufacturing Execution Systems (MES).
- Laboratory Information Management Systems (LIMS).
- IT infrastructure and security.
- Data integrity assessment and Data integrity issues resolution plans.
Quality Management Services:
- Quality Tabletop Audit and Quality Issues Simulation
- Analytic Testing Tools
- Quality Systems Implementation Plan
- FDA Product Jurisdictional
- Compliance Assessment and Auditing
- Quality Gap Analysis
- Federal and State Government Inspection Readiness
- Internal, Supply Chain ATP business partners and Independent Audit Support
- Remediation Plan and Execution
Supply Chain Manufacturing and Packaging Services
In addition to assisting with the manufacturing and/or packaging facilities operational consultative services, Advasur ATP also has a team of trainers for GMP procedures and processes documentation production to line staff training programs.
Our Manufacturing/Packaging subject matter experts can also serve as Project Oversight Committee members or act as the initial Project Manager until an internal hire is made to replace our team member. Advasur ATP Manufacturing Team members can assist with he implementation of correct Good Manufacturing Processes, operating systems, and interoperability engineering design between components, including but not limited to:
- Line design, buildout, and retrofitting where required.
- Line Installation and QC/QA programming.
- Selection and deployment of Automation equipment.
Identification, evaluation, contracting support with Contract Manufacturing Organization(s)
