“Whether it is wholesome consulting project or a part of the process improvement, we conduct a thorough and effective GMDP, GDP and Biotech consultation through.”
Overall gap analysis and assessing the adherence to required regulatory compliance, revamping the process and documentation to simplify and streamline their internal process, audit oversight, scheduling audit planning, full management/planning of audits.
General and subject matter specific trainings .
Green field and brown field project consultation.
For-cause audit, Audit preparedness, mock inspections for internal improvement, Dos and Donts before, during and after the audit process.
Crisis avoidance and preparing the responses for the deficiencies cited by regulatory agencies.
Supplier qualification, management and GxP vendor assessment.
Equipment qualification, contract FAT service at the equipment fabrication sites.
