Life Sciences Advisory, Consulting, Workforce Development, Training Service
GXP Consulting Services
Audits
We conduct international GCP, GMP, GLP, GCLP and CSV, including sites, IRB/IECs, CROs and specialty Service Providers audits. Our Auditors possess at least 10 years experience for a comprehensive and quality driven audit.
Quality Management System
We support development of your company QMS and department quality management functions and procedures with expertise and efficiency for your organization
Procedural Documents
Our procedural document development have deep experience in the subject matter and composing these documents there for your procedures are compliant with applicable regulatory requirements. And, the procedures reflect your organization's quality requirements, workflow and processes for ease of implementation.
Mock Inspection
Leveraging our international auditing and regulatory authority inspection experience, we can support any country's regulatory requirements for a smooth and compressive mock inspection using our partnership approach to maximize the learnings towards effective and targeted preparation.
Regulatory Authority Inspection Support
Our GXP support is provided as a ''planned work stream - initiative'" and FOR CAUSE AUDITS globally.
GXP and CSV Training
Our trainings are provided virtually and in-person globally to meet the time zone requirements of participants for maximum learning impact.
ICH GCP E6 3 EXPERTS YOUR TRUSTED PARTNER
Experts Diving Deep into the Changes for YOU!
We have performed the comparison to ICH E6 GCP R2 to the proposed changes in ICH GCP E6 R3 for informed and solutions-oriented training and GCP consulting.
Why JOIN us in this complimentary program.
Expert Insights & Explanations
Gain clarity on the proposed changes with our detailed explanations and expert insights. Understand the significance of each change and how regulatory communications and inspections have influenced these updates.
Implementation Tips
Receive practical advice on how to incorporate the proposed changes into your practice effectively. Our expert recommendations will help you stay compliant and ahead of the curve.
Stay Ahead
Ensure you are well-prepared for the ICH GCP E6 (R3) changes by attending our webinars and reading our newsletters.
Continuous Learning
Keep pace with the evolving regulatory environment through our regular updates and insights.
Expert Guidance
Benefit from the knowledge and experience of industry leaders who provide actionable advice and information.
Results You Can Expect
Enhanced Compliance
By keeping up with the changes, you'll ensure your practices meet the latest regulatory standards, reducing the risk of non-compliance.
Improved Efficiency
Implementing the proposed changes with our tips will streamline your processes, leading to a more efficient workflow.
Greater Confidence
Stay confident in your operations as our guidance and insights mitigate uncertainty and prepare you for implementation on DAY 1 of the final guideline publication in Q1 2025.
Up-to-date Knowledge
Always be in the know with current regulatory requirements and industry best practices, boosting your credibility and capability.