Testing Services
Testing Services
About our testing services
At PharmaPure, our Comparability Studies ensure your drug products maintain quality, safety, and efficacy when undergoing changes like site transfers, process updates, or reformulations. We design risk-based protocols and provide IVRT, IVPT, analytical testing, and regulatory support to keep your products compliant and consistent.
Our In-Vitro Testing Capabilities offer predictive, reproducible data on topical and transdermal formulations. Using advanced models that simulate human conditions, we help optimize formulations, demonstrate bioequivalence, and meet FDA, EMA, and ICH requirements—accelerating development while reducing risks.
Comparability Studies Establishing Equivalence. Enabling Change. Ensuring Confidence.
Change is a natural part of the lifecycle of any pharmaceutical product. This can include transitions to a new manufacturing site, updates to equipment, changes in processes, or reformulation of excipients. However, it’s crucial that these changes do not compromise the product’s quality, safety, or efficacy.Â
This is where Comparability Studies come into play.Â
At PharmaPure, we design and implement comparability protocols to rigorously evaluate the impact of manufacturing or formulation changes on your drug product. Our specialized expertise in semisolid and topical formulations ensures that any changes are data-supported, maintaining product consistency, compliance, and regulatory approval.Â
When Are Comparability Studies Required?
Comparability assessments are essential whenever changes could potentially affect the product’s critical quality attributes (CQAs). Common triggers for these assessments include:Â
- Site transfers or equipment upgradesÂ
- Process scale-up or optimizationÂ
- Changes in raw material suppliers or gradesÂ
- Reformulation of inactive ingredientsÂ
- Updates to container-closure systemsÂ
- Post-approval variations or lifecycle managementÂ
Without proper comparability data, even well-intentioned changes can result in delays in approvals or lead to regulatory challenges. PharmaPure helps ensure that your modifications are scientifically justified and comply with regulatory requirements. Â
Our Capabilities
Our Comparability Studies are grounded in regulatory guidelines (such as ICH Q8/Q9/Q10) and align with the expectations of regulatory agencies like the FDA and EMA. We provide:Â
- Design of Comparability Protocols:Risk-based study designs that isolate, analyze, and justify product changes.Â
- In Vitro Release Testing (IVRT):Evaluation of product performance consistency across batches or formulations.Â
- In Vitro Permeation Testing (IVPT):Assessment of skin absorption profiles before and after changes to determine bioequivalence or Q1/Q2 sameness.Â
- Analytical & Physical Characterization:Comparison of rheology, pH, viscosity, appearance, and other critical parameters.Â
- Statistical Analysis & Reporting:Interpretation of data using validated statistical methods, along with documentation that is ready for submission.Â
- Regulatory Support:Expert assistance for briefing books, supplements, and communications with regulatory agencies.Â
De-Risk Change with Confidence
Change doesn’t have to equate to risk. With PharmaPure’s expertise in comparability, you can adapt your processes or supply chain while ensuring the integrity of your product remains intact. Â
Let’s focus on what truly matters—ensuring your product continues to deliver results.
In-Vitro Testing Capabilities
At PharmaPure, our in vitro testing capabilities offer industry-leading insights into the performance, safety, and efficacy of topical and transdermal formulations. By utilizing highly controlled, reproducible, and scientifically validated methodologies, we assist our clients in optimizing formulations, demonstrating bioequivalence, and confidently meeting regulatory requirements.
Our in-vitro models are designed to replicate human physiological conditions, enabling robust, predictive, and scalable testing across various delivery routes, including dermal, mucosal, ophthalmic, otic, respiratory, and ungual applications.
Why Choose PharmaPure for In Vitro Testing?
Regulatory Excellence – All our testing methods comply with FDA, EMA, and ICH guidelines.
Predictive & Reproducible – Our models produce highly reproducible data that correlate with in vivo performance.
Cutting-Edge Technologies – We use proprietary automated diffusion cells and high-resolution imaging to deliver advanced analytics.
Customized Testing Solutions – Whether you need early-stage screening or late-stage validation, our scientists tailor studies to meet your specific development requirements.
With decades of experience in topical and transdermal drug development, PharmaPure is the preferred partner for pharmaceutical companies looking to mitigate risks and accelerate their market entry.