We are a consulting firm with a very niche market. We help Life Science companies (pharmaceutical companies and also medical device companies) get and stay in compliance with all of the complex regulations placed upon them by governments around the world - for example the US FDA.
Our passion is to continuously advance regulatory compliance in the Life Science industry. That means we pioneer new methodologies and technologies, benchmark industry performance, and help our clients bridge the gap between their technical departments and their business departments.
Our vision is to one day completely eliminate regulatory compliance challenges for our customers. We do that by continuously improving regulatory compliance in the Life Science industry.
Why do clients call us? They call us when they change their system landscape (ie. get new IT systems like ERP systems, manufacturing systems, etc). They also call us when they need to understand and conform to new regulatory requirements coming from governments around the world. And, they call us when they are simply trying to improve their current compliance level.
Really detailed info: What exactly do we do for our clients? We provide:
Compliance and Validation Services
IT Strategy Advisory
Inspection Readiness / Mock Audits
System Search and Selection
Document and Quality Management Systems
We are specialists in regulatory compliance issues such as:
Serialization / Track & Trace
Regulated Medical Mobile Applications