Below is a list of popular client requests in Quality & Compliance.
Strategic QMS design
Phase-appropriate QMS roadmap planning
Foundational QMS framework: see more about this offering here!
QMS gap assessment
QMS gap assessment
QMS roadmap
Document authoring, review, and revision
Standard operating procedure (SOP) authorship
Quality system documentation authorship
Quality system documentation review
Quality Operations
Support with investigation, impact assessment, resolution of GMP related adverse events such as environmental monitoring events, deviations, out of specification results, non-conformities, process failures
Execution of records and administrative activities within the QMS
Provide quality oversight representation to external stakeholders
Support project management of quality operations
Good clinical practice (GCP) support
Good laboratory practice (GLP) support
Audits
Vendor audits
CDMO audits
Mock pre-licensure inspection (PLI) support
Other mock audits, including FDA inspection dress rehearsal, clinical phase GMP audit, or strategic session.
