Our Services
“Whether it is wholesome consulting project or a part of the process improvement, we conduct a thorough and effective GCP, GMDP, GLP, BA/BE and CSV 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.
- Good clinical practice services, Bio Availability and Bio Equivalence services.
- Good Laboratory practice services.
- 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.
- Computer system validation (CSV) services.