Global GxP Solutions: Compliance Solutions for the Life Science Industry
Marc Booker, CEO
The evolving demands of regulatory agencies and the requisite globally competitive edge in today’s market; the life science industry has been for cedto do things differently. Increasing reliance on newer technologies, global supply chains and increasing patient demands can mean companies can easily fall prey to regulatory issues. Today the Life Science industry appears to be a weak link due to its direct impacton patient safety and public scrutiny. This is where Global GxP Solutions strategically partners and provides innovative solutions for any segment of the life science industry that ensures compliance and strives for operational effectiveness. Christopher Gambale, comments, “We, at Global GxP Solutions, have scalable programs and technology solutions that match the life cycle development of the product from pre-clinical to commercial manufacturing as well as post market surveillance.”
Head quartered in Las Vegas, Global GxP Solutions (GGxPS), flag ship services include staff augmentation, remediation efforts and system optimization. The company relies on its two basic principles, direct expert access and the vision of “for consultants by consultants.” As Global GxPS’ solutions are value based it utilizes its collective industry experience to assist life science organizations to successfully navigate through the ever changing regulatory environment. Next, its ‘for consultants by consultant’ principle creates a win-win partnership for its clients. This business model not only allows consultants to be creative in fulfilling the clients’ needs, but also to fulfill client expectations at a higher capacity, without having to worry about income and expenditure. Right from product conception to realization, it provides services consistently. Ben Mayatt states, “We are proud of our team for our ability to offer out of the box solutions that ultimately lends itself seamlessly to the process of the lifecycle development of a product.”
Global GxP Solutions serves as a one-stop resource for technical and compliance expertise in Clinical (GLP), Clinical (GCP), Commercial (GMP), Post Marketing (GVP), and automated computerized system (GAAP).
The company provides onsite support and inspection readiness techniques and licensing support. From a system optimization stand point Global GxP Solutions has partnered with clients to provide step changes through effective compliance strategy development, planning and resourcing. It works collaboratively with customers to develop methodologies and process that are in line with compliance expectations and provides regulatory compliance education to international clients to promote a quality culture. “Our programs are well thought out and seek to address systemic issues and not just quick fixes,” explains Marc Booker. Global GxPS’ deep industry knowledge enables it to build compliant Quality System and trust with global regulatory bodies and ultimately the patients served.
From a system optimization stand point Global GxP Solutions has partnered with clients to provide step changes through effective compliance strategy development, planning and resourcing
Global GxP Solutions’ major areas of expertise are its response to regulatory agencies and development, deployment and execution of broad based GxP remediation programs. GGxPS 483 Responses, Remediation programs, and subsequent CAPA development and implementation are market proven and industry leading. This strategic remediation planning and deployment have lead organizations to successfully overcome regulatory actions such as warning letters and consent decree. As a top-notch consulting firm, Global GxP Solutions thrives to assist its clients, whether it’s rebuilding trust from both regulatory and public bodies, or offer interim leadership support; provided solutions are realistic and sustainable. Their present client list is comprised from varied industries such as Pharmaceuticals, Medical Devices, Biotechnology, Clinical Operations, CRO, Contract Laboratories, GLP Service Providers and Market Research Providers.