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Achieve Regulatory Compliance with Expert GCP Support
We are dedicated to maintaining the highest standards of Good Clinical Practices (GCP), which are crucial for safeguarding the integrity, safety, and effectiveness of clinical trials. GCP offers a comprehensive framework that directs the design, execution, monitoring, and reporting of clinical research, ensuring all studies are conducted with ethical and scientific rigor. Our commitment to quality is foundational to everything we do.
Offering consultancy, gap analyses, and operational support on GCP topics
Developing, implementing, and optimizing your GCP quality system
Preparing applications for manufacturing and wholesaling authorizations
Creating and documenting processes as Standard Operating Procedures (SOPs)
Implementing risk management strategies, including RBQM analysis
Planning and conducting GCP audits and self-inspections, including CAPA management
Preparing for and supporting health agency inspections
Comprehensive Services Tailored for Clinical Trials
Auditing Services
- Investigator Site Audits: Thorough evaluations of investigator sites to ensure compliance with GCP and trial protocols
- Vendor and CRO Audits: Comprehensive assessments of vendors and Contract Research Organizations to maintain high-quality standards
- Trial Master File (TMF) Audits: Detailed reviews of TMFs to ensure completeness, accuracy, and regulatory compliance
Request for Proposal
Our comprehensive GCP solutions ensure that your clinical trials are conducted ethically, safely, and efficiently, meeting all regulatory requirements. Contact us today!