Products Development

WES Pharma’s highly skilled scientific team is capable of utilizing sophisticated techniques and technologies in their product development work. Our scientists and chemists apply the physicochemical attributes of the drug, excipients and the finished product in connection with the pharmacokinetic parameters of the drug and dosage form in the development of the drug delivery system. The use of statistical design and mathematical modeling with consideration of pharmacokinetic principles in formulation development enables WES’s scientists to develop a product with a predictable outcome that offers higher assurance in the success of bio/clinical studies. In addition, WES’s scientists integrate quality and regulatory requirements into the development program, giving higher assurance of fast track product review, approval and launch.

Pre-Formulation

Proper Pre-formulation research is the key to successful development of a product with a high probability of meeting bio-performance, stability, optimum process, that addresses recent FDA science-based review requirements. Pre-formulation is often an under-utilized step in Product Development. This scientific research saves time and resources during development. Such activities are included, but not limited to:

• Polymorphism

• Micromeritics - Particle Properties

• Thermal Analysis

• Drug-Excipient Interaction

• Viscoelastic Behavior

• Solid-state Characterization

• Micro and Nanotechnology Analysis

• Matrix hydration & drug diffusion

Formulation

• Mathematical Simulation Modeling

• Modified Release Technology (Micro/Macro particle, Matrix, Coating)

• Optimize and Improve Bioavailability

• In-vivo/In-vitro Correlation

• Robust Manufacturing Process

• Integrate Quality & Regulatory Requirements

Analytical Services

• Physical and Chemical Characterization

• Polymer characterization (Mn , Mw , DS, functional group analysis etc.)

• Method Development, Optimization and Validation

• Bio-indicative release

• Pharmaceutical Equivalency of Complex Molecules

• API Development Support

• Polymorph Screening

• Stability Studies

Customer Concerns and Product Issues

Phone: +1 888-212-6921

Email: wespharma_micc@mitoconbiopharma.com

• Please note, we cannot respond to questions about general medical information or questions regarding your personal medical condition. If you have questions about a specific medical condition, please consult a healthcare professional.