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. 

This is where Comparability Studies come into play. 

At MedPharm, 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. 

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: 

• Site transfers or equipment upgrades 

• Process scale-up or optimization 

• Changes in raw material suppliers or grades 

• Reformulation of inactive ingredients 

• Updates to container-closure systems 

• Post-approval variations or lifecycle management 

Without proper comparability data, even well-intentioned changes can result in delays in approvals or lead to regulatory challenges. MedPharm helps ensure that your modifications are scientifically justified and comply with regulatory requirements.  

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: 

• Design of Comparability Protocols: Risk-based study designs that isolate, analyze, and justify product changes. 

• In Vitro Release Testing (IVRT): Evaluation of product performance consistency across batches or formulations. 

• In Vitro Permeation Testing (IVPT): Assessment of skin absorption profiles before and after changes to determine bioequivalence or Q1/Q2 sameness. 

• Analytical & Physical Characterization: Comparison of rheology, pH, viscosity, appearance, and other critical parameters. 

• Statistical Analysis & Reporting: Interpretation of data using validated statistical methods, along with documentation that is ready for submission. 

• Regulatory Support: Expert assistance for briefing books, supplements, and communications with regulatory agencies. 

De-Risk Change with Confidence 

Change doesn’t have to equate to risk. With MedPharm’s expertise in comparability, you can adapt your processes or supply chain while ensuring the integrity of your product remains intact.  

Let’s focus on what truly matters—ensuring your product continues to deliver results.