BiggsB
BiggsB is a regulatory compliance and implementation company specializing in the Life Sciences and Bio Medical Industries. With over 20 years of experience, they focus on making compliance simple, cost-effective, and human-centered. They serve a diverse range of clients from global corporations to startups, providing end-to-end compliance and project management services. Their approach emphasizes communication, creativity, strategy, and seamless data integration, aiming to reduce compliance costs and avoid bureaucratic headaches.
Industries
Nr. of Employees
small (1-50)
Services
Consulting and implementation services to establish and operate regulatory compliance programs for life sciences organizations.
Validation of regulated computerized systems and delivery of IT compliance solutions, using hybrid project methodologies tailored for validation needs.
Design and implementation of quality management systems and related procedures to meet regulated requirements.
Commissioning and qualification services for laboratory equipment and facilities, including qualification protocols and execution.
Audit services for vendors and suppliers against regulated frameworks such as FDA, CLIA, SOX, and HIPAA.
Planning and execution of projects and portfolios for regulated initiatives, including resourcing, scheduling, and delivery oversight.
Consulting and implementation services to establish and operate regulatory compliance programs for life sciences organizations.
Validation of regulated computerized systems and delivery of IT compliance solutions, using hybrid project methodologies tailored for validation needs.
Design and implementation of quality management systems and related procedures to meet regulated requirements.
Commissioning and qualification services for laboratory equipment and facilities, including qualification protocols and execution.
Audit services for vendors and suppliers against regulated frameworks such as FDA, CLIA, SOX, and HIPAA.
Planning and execution of projects and portfolios for regulated initiatives, including resourcing, scheduling, and delivery oversight.
Expertise Areas
- Regulatory compliance management
- Computerized system validation (CSV)
- Quality systems development
- Informatics and data integration
Key Technologies
- Computerized system validation
- GxP compliance frameworks (GLP, GMP, HIPAA)
- Informatics and system integration
- Hybrid Agile/Waterfall project methodologies
News & Updates
Site Closure Under Extreme Pressure
Decommissioned or transferred 44 GxP systems, communicated plans to 2,500 staff, and closed a site under a brutal timeline.
Global Compliance Management for a Healthcare Company
Managed global compliance from a site in Northern California, supporting growth and system implementation.
Site Closure Under Extreme Pressure
Decommissioned or transferred 44 GxP systems, communicated plans to 2,500 staff, and closed a site under a brutal timeline.
Global Compliance Management for a Healthcare Company
Managed global compliance from a site in Northern California, supporting growth and system implementation.