How We Can Help
Auditing
Auditing is a necessary part of operating a cGMP or Medical Device Regulation compliant pharmaceutical or medical device company. From supplier audits to internal audits and confidential investigations, we can do it all on a global basis. And if you are looking to grow by acquisition, we are experts at assessing the FDA compliance risks presented by potential acquisition targets.
Regulatory Agency Responses
We've had many years of consulting experience helping regulated firms respond to FDA and other global regulatory agency cGMP inspectional observations and Warning Letters. We also help you to develop appropriate CAPA and remediation plans. We have a proven track record of working with our client's SMEs to develop responses that can help avoid additional regulatory actions and help ensure future cGMP and/or MDR compliance.
Development of Compliant Quality Systems
We provide FDA cGMP compliance consulting for new start-ups and virtual companies to help develop stage and scale-appropriate Quality Systems that meet current regulatory agency expectations. This includes the integration of Quality Risk Management, Quality Metrics and Management Responsibility with the Quality System to ensure cGMP compliance sustainability.