About Us
Welcome to LBC Pharmaceutical Professionals, LLC
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 Approach
At LBC, we understand that each client is unique. We listen carefully to your needs, align expectations, and execute projects with precision and efficiency. By leveraging our global network of experts, we ensure you receive innovative solutions tailored to your specific challenges. Our services meet local and global regulatory requirements compliant with standards at the FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA and many other agencies governing medicinal products. And, our services meet the most stringent Quality Management System standards.
LBC services range from filling specific role-based positions to managing defined projects, including the following:
- Case Management: Processing ICSRs and managing data migration.
- Regulatory Reports: Preparing, evaluating, and analyzing aggregate data.
- Signal Detection: Monitoring safety data for potential risks.
- Risk Management: Developing and implementing strategies to mitigate adverse effects.
- Process Optimization: Enhancing systems, processes, and organizational structures.
- Audits: Conducting compliance assessments and preparing for inspections.
- Optimizing Business Partnerships: Negotiating and facilitating safety data exchange agreements.
- Teaching and Training: Providing comprehensive pharmacovigilance training.
Our Commitment
We are committed to excellence in everything we do. Our dedication to patient safety, regulatory compliance, and operational efficiency drives us to continuously improve and deliver the highest quality services. We look forward to partnering with you to achieve your pharmacovigilance and risk management goals.
Reach Out
Our Network
LBC matches each client with consultants whose education, training, and experience are appropriate for meeting business objectives. Our consortium of consultants enables us to engage with clients on a wide range of services and resource multiple projects concurrently. We have successfully worked with small start-ups, mid-sized biotech companies, and large pharma in the US, Europe, and Japan, ensuring flexibility and scalability in our approach.
Reach OutOur Founder
Lauret Ballsun
Lauret focused on specific patients and their families during her early career as an RN working in the newborn intensive care unit. While this work was incredibly rewarding, Lauret continued to think about public health issues, which was a primary focus in her education. Lauret wanted to leverage her work to help larger groups of patients.
Lauret was introduced to the field of pharmacovigilance in the late 1980’s, which was a time when national and international standards and regulations were undergoing fundamental and dynamic changes. Over the next 18 years, Lauret grew and developed systems, processes, and infrastructure at four companies, Syntex, Genentech, Elan Pharmaceuticals, and ICOS. Lauret’s interest in optimizing efficiency while obtaining the highest quality outcomes gave her opportunities to design and engineer new organizational structures and implement new systems. Lauret founded LBC in 2007 in order to leverage her experience and the experience of many other pharmaceutical professionals in the set-up and deployment of pharmacovigilance activities.
Lauret often refers to the convergence of three primary areas of knowledge in pharmacovigilance…
- Medical knowledge is required so there is a succinct and cogent story about each patient and about groups of patients,
- Regulatory knowledge is required so solutions are compliant with requirements and leverage the best industry standards,
- Data about patients needs to be captured, stored, and retrieved in systems and databases that are rigorously validated to satisfactorily answer critical questions from clinical trials and post-marketing experience.
Lauret is passionate about finding answers to puzzles and welcomes doing this in a dynamic and interactive relationship with clients. Lauret established LBC so clients have a creative partner to effectively and efficiently meet new challenges.
