Innovative, Science-Driven Formulation Strategies

At MedPharm, our Formulation Development services provide a rigorous, scientifically driven approach to developing safe, effective, and scalable pharmaceutical formulations. Leveraging Quality by Design (QbD) principles, we integrate API characterization, pre-formulation studies, in silico modeling, and in vitro testing to optimize drug performance and mitigate risk before reaching costly clinical phases.

We specialize in topical, transdermal, nasal, ophthalmic, otic and other complex drug delivery routes, offering a tailored approach to ensure the best formulation strategy for your product.

Early-Stage Evaluation & Strategic Planning

Before formulation development begins, we conduct a comprehensive assessment of your active pharmaceutical ingredient (API) and target product profile. This critical first step helps identify potential challenges and streamline the path to clinical success.

Pre-Formulation
Early studies assess API properties, excipient compatibility, and formulation feasibility to de-risk development.

Target Product Profile Development
Defines key characteristics to guide formulation design, ensuring alignment with regulatory and market requirements.

API Characterization
Evaluates the API’s physicochemical properties, solubility, stability, and polymorphism to inform formulation strategy.

In Silico Prediction & In Vitro Assessment
Uses computational and laboratory models to rank API performance, optimizing formulation decisions early.

Learn more about how our early-stage evaluation helps de-risk and accelerate your development below.

Formulation & Optimization

MedPharm takes an iterative, data-driven approach to developing stable, effective, and scalable formulations. By optimizing multiple prototype formulations in parallel, we ensure that the most promising candidate is selected for further development.

Formulation Development
Iteratively refines prototypes to meet efficacy, stability, and manufacturability criteria.

Preliminary Process Assessment
Evaluates formulation scalability and identifies critical process parameters for future scale-up.

Reverse Engineering
Analyzes reference-listed drugs (RLDs) to develop generics, ensuring in vitro bioequivalence and regulatory compliance.

Lead Formulation Selection
Identifies the optimal formulation through risk assessment, in vitro testing, and performance optimization.

Learn more about how our formulation expertise accelerates your path to clinical success below.