Internal, supplier, and mock inspection audits, gap assessments, and compliance support for GMP, GLP, and device quality systems. We assess a quality system against FDA and ICH expectations, write findings that hold up, and drive corrective actions to closure.
Planned audits of your own quality system and of the suppliers, CMOs, and CDMOs you depend on.
Practice inspections that test your documentation, systems, and people before the agency does.
A structured comparison of your procedures and practices against FDA and ICH expectations, including QMSR gap assessments for device makers.
Review of records, systems, and audit trails for data integrity risk.
Help preparing for inspections and responding to observations.
A biotech preparing for its first FDA pre-approval inspection needs contract compliance and CSV support, including mock inspections, documentation review, and validated systems and electronic records that meet Part 11 and Annex 11 requirements before the inspection window.
A compliance and audit specialist supports a supplier audit program, planning and conducting audits and driving findings to closure.
A medical device manufacturer closing gaps against the FDA QMSR and ISO 13485 needs contract quality and compliance support for its procedures, design controls, and CAPA process. If a new ERP or eQMS is involved, the team also needs validation support.
An audit or gap assessment program with a defined scope, schedule, and written deliverables.
A compliance and audit specialist embedded in your team to run or support your audit program.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.