We optimize your product’s value to enable a successful drug / medical device development analysis process.
We accelerate your drug or device development program with expert insights and advanced data analysis as applied to the product development strategy.
- Project management: By identifying key tasks, we manage your project including the integration of tasks with timelines, budget and interdependencies. We provide advice for improving your project management for these aspects.
- Product Development Plan: This maps key issues for your project from Discovery to Development to Clinical based on your Product Profile.
- Assessment of potency and efficacy models: Cell-based, Functional, Animal-based, Mechanism-based, as relevant to your project needs.
- Assessment of CMC issues for biologic product candidates: Choice of expression system, Process and Formulation strategy, Initiate and manage relationships with relevant CROs and CMOs, Develop assays for release, characterization, and stability testing of the product.