Turning Scientific Insights into Scalable, High-Performance Drug Products

At MedPharm, Characterization & Optimization is the critical phase where formulation science meets process precision. This step enables our scientists to refine every aspect of your drug product—transforming early-stage concepts into scalable, stable, and therapeutically effective solutions.

Our integrated approach begins with detailed product characterization to establish a strong foundation of performance data, followed by targeted process optimization using Quality by Design (QbD) principles and robust analytical techniques. Whether you’re preparing for clinical trials or full-scale manufacturing, this stage ensures your formulation is ready to advance with confidence.

What We Do in Characterization & Optimization

Product Characterization
We perform a full suite of physicochemical, rheological, and performance-based evaluations to define your product’s unique attributes and behaviors, including:

• Viscosity, particle size, and pH analysis
• Rheological profiling to evaluate texture and spreadability
• In-vitro release and permeation testing
• Stability under stressed conditions (temperature, light, humidity)
• Analytical fingerprinting for batch consistency

These data points inform critical decisions around formulation refinement, scalability, and regulatory compliance.

Process Optimization
Using Design of Experiments (DoE) and process simulation tools, we fine-tune every manufacturing parameter—from mixing speeds and order of ingredient addition to thermal profiles and hold times. Optimization ensures:

• Reproducibility at different batch sizes
• Reduced cycle times and improved efficiency
• Robustness under real-world manufacturing conditions
• Compliance with FDA and EMA expectations for critical process parameters (CPPs) and critical quality attributes (CQAs)

Integrated Tools & Technologies

• Automated high-throughput screening for rapid formulation refinement
• Real-time monitoring with in-line and at-line analytics
• Moisture sorption and degradation studies
• Design space mapping to define safe and effective operating ranges
• Custom stability protocols to assess product shelf-life and resilience

Why MedPharm’s Approach Stands Out

Formulation + Process Synergy
Our formulation scientists and process engineers work together to ensure consistency from lab to line, ensuring product performance isn’t compromised during scale-up.

De-Risked Development
By resolving performance and process issues early, we reduce downstream manufacturing risks and regulatory delays.

Tailored to Your Delivery Route
Whether you’re developing a gel, spray, lotion, patch, or aerosol, our methods are tailored to the unique demands of topical, transdermal, and mucosal drug delivery.

Compliant from the Start
All work is conducted in alignment with ICH, FDA, and EMA guidelines to support IND, NDA, ANDA, and IMPD submissions.

Your Product’s Potential, Fully Realized.

With MedPharm’s Characterization & Optimization services, your formulation isn’t just tested—it’s validated, refined, and prepared for success. We ensure your product performs as expected, is stable under stress, and is fully compatible with commercial-scale production processes.