Our Services
Leading the Way in Pharmacovigilance
Lauret Ballsun founded LBC Pharmaceutical Professionals, LLC (LBC) in 2007 to solve client driven business goals by optimizing Pharmacovigilance services throughout the life cycle of a medicinal product that harmonize with regulatory requirements and industry standards.
LBC focuses on working with clients to find a solution that is ‘right-sized’ for the company based on the stage of medicinal product development.
The solutions include filling specific role-based positions and/or working on defined projects.
Projects include:
- Developing and implementing processes to manage safety data
- Building and/or re-engineering infrastructure
- Analyzing safety data to identify product risks
- Supporting client programs implemented to mitigate product risks
- Partnering with clients on product approval applications
- Writing and publishing planned or ad hoc submissions to regulatory agencies
- Establishing and maintaining practices in compliance with quality assurance standards.
Our Services
Unique Capabilities for Your Company's Success
Case Management
Comprehensive processing of ICSRs from intake to submission, ensuring efficient data migration between safety databases.
Regulatory Reports
Preparation, evaluation, and analysis of aggregate data to meet stringent regulatory requirements.
Signal Detection
Monitoring and assessing safety data to identify new or potential risks.
Risk Management
Developing and implementing strategies to mitigate adverse effects, including RiskMAPs and REMS.
Process Optimization
Reviewing and enhancing systems, processes, and organizational structures to improve efficiency and quality.
Audits
Conducting thorough compliance assessments and preparing for regulatory inspections.
Optimizing Business Partnerships
Facilitating the exchange of safety data between business partners and negotiating safety data exchange agreements.
Teaching and Training
Providing focused seminars and comprehensive pharmacovigilance training.
LBC Pharmaceutical Professionals has been an invaluable partner in our pharmacovigilance efforts. Their expertise and dedication to risk management have significantly enhanced our compliance and safety processes. We highly recommend their services.
Robert D.
CEOWorking with LBC Pharmaceutical Professionals has been a game-changer for our company. Their comprehensive approach to pharmacovigilance and risk management has streamlined our operations and ensured regulatory adherence. Exceptional service!
Sarah P.
Director of Regulatory AffairsLBC Pharmaceutical Professionals’ team is incredibly knowledgeable and responsive. Their consulting services have greatly improved our pharmacovigilance systems, allowing us to focus more on innovation and growth. They are true industry experts.