Transforming Concepts into Clinical-Ready Products

At MedPharm, the Selection & Optimization phase represents a crucial turning point where early-stage insights evolve into refined, high-performing formulations designed for success. By leveraging comprehensive data from pre-formulation studies, physicochemical analysis, and in-vitro testing, our scientists transform promising concepts into viable drug product candidates that are ready for clinical development and regulatory advancement.

This stage is where scientific expertise meets precise engineering. Our formulation experts combine decades of experience with automated high-throughput platforms and a rigorous Quality by Design (QbD) framework to fine-tune dosage forms for real-world performance. We optimize for drug efficacy, stability, manufacturability, and patient usability, ensuring that each formulation not only meets your Target Product Profile (TPP) but also aligns with global regulatory standards and commercial viability.

Whether you are advancing a new chemical entity or reverse-engineering a generic product, our iterative and data-driven development model accelerates your timeline, reduces formulation risk, and prepares your drug product for clinical trials with confidence.

Our Selection & Optimization Services

Formulation Prototype Preparation

We create multiple formulation prototypes across various dosage forms (e.g., creams, ointments, gels, sprays, patches) based on active pharmaceutical ingredient (API) characterization and delivery objectives. These prototypes are rigorously screened for performance and manufacturability.

Lead Formulation Selection

Using predefined success criteria, our team assists in selecting a lead formulation and backup option based on in vitro performance, stability, scalability, and regulatory alignment. Client collaboration is central to this process, ensuring your product goals remain prioritized.

Preliminary Process Assessment

For both novel and generic formulations, we assess manufacturing feasibility early. We analyze processing parameters such as mixing, temperature control, and order of addition to identify optimal approaches and reduce scale-up variability.

Reverse Engineering (for Generics)

When developing generic equivalents, we reverse-engineer reference listed drugs (RLDs) to match their composition and microstructure. Our state-of-the-art analytical techniques ensure bioequivalent performance while enabling efficient replication.

Optimization Tools & Techniques

• Design of Experiments (DoE) for robust process understanding
• Automated High-Throughput Screening for efficiency and repeatability
• Integration of In-Vitro Testing for release, permeation, and biological activity
• Short-Term Stability Studies to identify formulation risks early

The MedPharm Advantage

• Streamlined transition from pre-formulation to clinical formulation
• Proactive risk mitigation through real-time testing and iterative development
• Global regulatory foresight integrated into every formulation decision
• A collaborative approach that keeps your goals at the forefront