Overview
AVANZA provides integrated Program Development and Implementation Services (PDIS) in response to client demand and in keeping with our continued effort to expand our comprehensive drug development and implementation services.
This program ranges in scope from stand-alone assignments intended to augment internal capabilities to strategic relationships managing the selection of a lead compound, and preparation of a drug development plan and implementation of that plan. By integrating the PDIS expertise with our non-clinical drug development services, AVANZA offers clients a comprehensive integrated solution to accelerate their drug development programs.
Our highly skilled professionals have experience with a number of drug candidate types (small molecules, vaccines, biologics, and gene/cell therapies) in a broad range of therapeutic areas (oncology/AIDS, infectious diseases, ophthalmology, immunology, cardiology, anesthesiology, and gastroenterology). Studies have been conducted for both commercial and government clients.
AVANZA's Program Development and Implementation Services include:
Program Planning and Execution
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Preparation of lead selection and drug development plans including animal models, efficacy and non-clinical safety studies
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Execution of plans using internal or external resources
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Subcontractor identification/assessment and qualification
Program Submissions, and Representation
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Review of integrated non-clinical summaries for regulatory agencies
Preparation and/or review of regulatory documents
Representation with clients before various regulatory agencies
Other Professional Services
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Utilizing our staff to augment your capabilities either on-site or remotely
Data interpretation and/or presentations including literature searches and position papers
Identification of experts in scientific areas to address your regulatory issues submissions
If you don’t see it listed here, please contact us with your specific needs.
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