Supplier audits, mock audits, gap assessments and CAPA management — holistic support for inspection readiness.
Audits of raw material, API, excipient and service suppliers under GMP & GDP. Finding management and qualification.
A comprehensive mock audit that simulates real inspection conditions. Team preparation and corrective action processes.
Assessment of the current quality system against current regulations, with a prioritised action plan.
Preparation, follow-up and effectiveness checks of CAPA plans arising from audit findings and deviations.
Setting up a periodic internal audit programme, qualifying internal auditors and integrating continuous improvement.
A comprehensive assessment of the quality system against regulatory requirements, with a findings report.
Quick wins and a medium- to long-term improvement roadmap based on risk-based prioritisation.
SOP revisions, completion of missing documents and closing system gaps.
Training on inspection behaviour, handling questions and team coordination. A simulated inspection.
On-site support during the inspection, finding management and help with preparing the CAPA plan.
Let's test your system under near-real conditions with a mock GMP inspection.