Monitoring Studies
Expert support for laboratory studies and regulatory compliance
QbD Group provides expert support for follow-up of laboratory studies required in the manufacture and quality of medicines, including method validation, results review, and report writing for regulatory submissions.
How can we help you?
The monitoring studies service assists in the follow-up of laboratory studies required in the manufacture and quality of medicines. We offer the necessary technical expertise to validate methods and help choose the most appropriate method.
We perform the review of results and assist in writing the final report for submission to the regulatory authorities. It is important to keep up to date with standards so that your processes comply with current regulations approved by regulatory authorities.
Why QbD Group?
End-to-end toxicology support
From early development to post-approval changes, integrated risk assessments aligned with QA, CMC, and regulatory strategies.
Trusted expertise at scale
Decades of combined experience providing reliable insights across diverse projects.
Proactive compliance monitoring
Strict oversight to keep clients ahead of evolving regulations.
Certified Toxicology Experts
EUROTOX-certified (ERT) toxicologists ensuring the highest scientific standards.
Our approach
Our team of highly qualified experts collaborates with you at every stage, ensuring meticulous and reliable results.
1. Project scoping
Define the monitoring study requirements and objectives.
2. Method validation
Help choose and validate the most appropriate analytical methods.
3. Results review
Thorough review of laboratory results and data interpretation.
4. Report writing
Assist in writing the final report for regulatory submission.
Why QbD Group
Your trusted partner
Whether you need support with laboratory follow-up, method validation, or environmental safety certification, our experts are here to help.
Scientific research support
meticulous and detail-oriented approach for accurate results.
Quality testing expertise
comprehensive validation and testing capabilities.
Regulatory submission support
reports prepared for regulatory authority requirements.
Certified Toxicology Experts
EUROTOX-certified team ensuring the highest standards.
Let's talk Toxicology
From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.