Your Gateway to Trusted QA & Compliance Solutions
Our Services
Following are different types of GCP / GCLP auditing services we perform, but not limited to..
CRO Qualification Audits
Evaluations to qualify potential Contract Research Organizations (CROs) before engagement.
Quality Management Solutions
We help organizations establish or enhance Quality Management Systems (QMS) tailored to their needs, integrating Quality by Design (QbD) principles and a risk-based approach.
Regulatory alignment
Ensuring organization is always inspection-ready for global regulatory audits.
Vendor Audits
Evaluation of third-party vendors providing services.
Full Clinical Trial audits and BA/BE studies
In-depth audits of complete clinical trials processes across all phases (Phase I-IV), including first-in-human and complex therapeutic trials. Thorough evaluation of clinical and bioanalytical component of BA/BE studies.
Risk based Monitoring
In process and retrospective.
Investigator Site Audits
Evaluation of clinical trial sites to ensure protocol and GCP compliance.
Quality Assurance (QA) Audits
End-to-end evaluation of QA frameworks within sponsor, CRO, or site organizations.
For-Cause Audits
Investigative audits conducted when issues arise during or after clinical trial, bio-analytical conduct.
GCP/GCLP Training
We deliver comprehensive training programs on GCP/GCLP/GDP fundamentals, Audit preparedness, Data integrity, and Refresher courses as per project need or regulatory requirements.