BiggsB, Inc: Bio and Pharma Regulatory Experts

The BiggsB Team provides comprehensive compliance and project management solutions for today's rapidly evolving companies in Biotech, Pharmaceutical, Medical Device, Contract Laboratories, Contract Research Organizations, and Equipment & Software vendors. ACT DO.TM -- These three words embody the BiggsB philosophy, which stems from 10+ years of battling fierce politics, fast deadlines and ever-cha

nging compliance standards. A well-planned strategy needs to be developed before it can be executed. And it doesn’t just work for the PMP. It’s the formula for success in any environment. Agilecsv TM -- We call this “the game changer”. It was developed as the solution to an industry-wide issue. Why do computer systems validation (CSV) projects only deliver 25% on time? Why are they managed so poorly? Why do they cost so much? Agilecsv TM combines the best of the agile iterative software development process with the traditional waterfall csv process and delivers a world-changing, game-changing, earth-shattering end result. Better. Faster. Cheaper. It’s our little secret weapon. This is our approach to compliance, csv, qualification, production, facilities, GMP manufacturing, GLP production, studies, trials, CLIA, lab process, HIPAA, and health protection. We combine the main elements of informatics and compliance to focus on people, computerized system, processes, and data.