LogicGate assists pharmaceutical, biotech, medical device, and life science organizations to effectively identify, manage, and implement changes driven by an ever-evolving regulatory, risk, and compliance landscape. Our technologies help merge people and process to manage risk and reduce cost.
Pharma and biotech companies face rigorous regulatory requirements from federal agencies like the FDA and global regulatory bodies such as the European Medicines Agency (EMA). There are also numerous industry best practices that govern drug development and manufacturing, such as cGMP and ISO standards. We have solutions that can help ensure these best practices are followed, including the requirements detailed in 21 CFR Part 11 regarding electronic records.
Regulatory, Compliance, & Legal Solutions
in Pharma, Biotech, & Life Sciences
LogicGate | Regulatory Compliance
LogicGate | ERM Solution
LogicGate | Incident Management Software
LogicGate | Policy Management Software
LogicGate | FCPA Compliance