At The Centre for Industrial Rheology, we provide expert rheological characterisation services tailored specifically for regulatory submissions for topical creams, lotions, gels, and ointments, ensuring your path to market is smooth, swift, and stress-free.
Regulatory agencies are requesting increasingly sophisticated analyses, as stated in the FDA guidelines:
“Physicochemical and Structural (Q3) Characterization of Topical Products” and the EMA “Guideline on quality and equivalence of locally applied, locally acting cutaneous products”
Leave Your Regulatory Rheology to Experts
Regulatory agencies such as the FDA and EMA scrutinise submissions meticulously. A minor oversight or questionable data can result in costly delays and resubmissions. Why risk setbacks when you can leverage decades of combined expertise and a proven track record?
Our team at The Centre for Industrial Rheology specialises in thorough rheological characterisation aligned with FDA and EMA Q3 guidelines. Our extensive experience ensures your submission-ready documentation meets and exceeds regulatory expectations from the outset.
World-Leading Rheological Equipment
We use high-performance, world-leading rheometers, providing unparalleled accuracy and repeatability.
Our instruments are qualified in line with IQ, OQ, and GLP 21.CFR Part 11 compliance and regularly calibrated against traceable standards, ensuring your data meets the highest levels of integrity and reliability. Furthermore, all rheological testing is conducted under stringent GMP/GLP conditions, providing fully compliant, high-quality data.
Rheology Profiling of Topical Pharmaceuticals
Our comprehensive service includes a customised test plan tailored specifically for your product. We rigorously analyse an appropriate number of lots of your test and reference products, capturing critical quality attributes essential for regulatory approval. Typically focusing on “spreadability” comparisons, depending on specific agency requirements, the quantified rheological parameters could include:
- Viscosity across the range of increasing and decreasing shear rates
- Yield stress determination
- Creep test measurements
- Thixotropic recovery assessments
- Linear viscoelastic response (G’, G”, crossover point, storage and loss modulus vs. frequency )
- Temperature sensitivity (as required)
We validate precision, reproducibility, and sensitivity, ensuring every measurement is reliable, robust, and defensible.
Advanced Statistical Analyses and Equivalency Evaluations
The Centre for Industrial Rheology provides extensive statistical analyses to support your regulatory submission. Our rigorous statistical equivalence evaluations include comparative assessments between your test and reference products using industry-standard methods such as 90% Confidence Interval analyses. Our approach ensures that the equivalence of your product is clearly demonstrated to regulatory authorities, significantly reducing the risk of rejection or requests for additional information.
Ongoing Rheology Support for Regulatory Queries
At The Centre for Industrial Rheology, our commitment doesn’t end with delivering a detailed, submission-ready report. We understand that regulatory agencies often have challenging, technical questions. That’s why we offer ongoing expert support to help you respond swiftly, confidently, and effectively.
No matter what regulators ask, our rheology specialists will be by your side, ensuring you can address queries with absolute confidence.
Peace of Mind, Delivered Rapidly and Professionally
With The Centre for Industrial Rheology, you gain more than precise rheological data—you gain the peace of mind knowing your regulatory submissions are in expert hands. Our rapid turnaround, professional approach, and ongoing support allow you to submit your products confidently, knowing you have a dedicated partner ensuring your success.
Make your rheology right the first time. Trust The Centre for Industrial Rheology – experts in rheological characterisation for pharmaceutical regulatory submissions.
Get in touch today to learn more about how we can streamline your path to approval