There is a whole team of experts available to support MedPharm’s clients.
Clinical Manufacturing Expert
The Clinical Manufacturing Expert has many years’ experience in working on manufacturing development projects for a wide variety of pharmaceutical companies. They are responsible for QbD, scale up and the delivery of toxicology and GMP batches. They are focused on de-risking transfer to commercial manufacturing scale.
The Analytical Scientist ensures our clients get the most appropriate analytical technique to evaluate their formulation and leads the development process to improve method efficiency. They have many years of experience in developing and validating a wide variety of techniques that can be incorporated into the commercial product specification.
Topical and Transdermal Formulator
Scientist with many years of experience focused on this niche area of drug product development. This role is often described as part art and part science and it takes many years of hands-on experience to fully appreciate these nuances. The Formulator supports MedPharm's clients in appreciating how critical formulation is for a particular route of delivery.
MedPharm’s bio-analytical expertise goes hand in hand with the development of performance models. The MedPharm bio-analytical scientists have years of experience working in areas of drug metabolism and pharmacokinetics in a wide range of tissues, specifically dealing with very low drug levels which often push the sensitivity of analytical methods in difficult matrices.
Our biologists are at the forefront of developing new models for demonstrating the pharmacokinetic and pharmacodynamic properties of our clients' compounds in skin and other tissues. Biologists work closely with our clients to ensure the most appropriate model is being used to de-risk clients’ development programs and ensure the optimal formulation is selected for any clinical studies required.
In addition to routine pharmaceutical microbiological techniques, MedPharm’s Microbiologists have developed novel infected tissue models in order to measure and optimize the performance of our clients’ drug substances, drug products and new formulation technologies. These now validated models can be used to justify bio-waivers for our clients' generic product submissions.
The Tissue Engineer has specialist knowledge in skin and epithelial biology that allows for bespoke model development. Many of our clients utilize MedPharm to help build models to assess in vitro or ex vivo biological activity and these models or systems range from single cell lines to complex 3D tissue cultures with functioning immune response.
Project manager who leads the overall program and serves as the single point of contact for the client. MedPharm is unique in that most in this role have an advanced degree and many years of development experience in the field of topical and transdermal delivery. The study director also has a consultative role to help guide our clients through the development process.