Consulting Services & Tailored Solutions

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.

 

 

Services

Pathology & Toxicology Services
Specializing in experimental pathology, our major expertise in efficacy and safety trials are GLP-compliant.
Consulting Services & Tailored Solutions
We optimize your product’s value to enable a successful drug / medical device development
Pre-Clinical Trials Management Services
The success of your study depends on efficient and effective execution of the experimental process.
Feasibility Studies
Design and execute your Proof of Concept study based on our methodology and tools. Integrate your Proof of Mechanism (PoM)

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