Challenge:
Rapid due diligence and valuation of compounds for critical decisions...Licensing Deal Structure
Manufacturing and Outsourcing strategy including determination of number of locations and in- source / outsource mix...
Management of Product Development of non-core product
Integrated early and full drug development plans
Quality Systems planning and implementation for developing company...
cGMP Quality System Gap Analysis for an established company...
Process development to address issues on a marketed product...
Site Audits with regulatory and practical operations perspective...
Manufacturing readiness assessment...
Sourcing - identification of sources and review / selection...
Candidate nomination process and portfolio review...
Formulation and drug delivery choices...
Market studies by simulating a pharma development group...
Deal valuation support...
cGMP Supplier Management...
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Solution:
The Right amount...of the Right resources...at the Right time for... Acceleration of Progress and Risk Management
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Benefit:
Trust and confidence that we will get it done...
World-class expertise that exactly meets the need...
Efficiency and effectiveness of our structured approach...
Avoid time consuming management and coordination of challenging resources and diverse inputs to complex issues...
Speed of results...
Accountability at a single, rather than multiple points...
We ensure a cross-functional and downstream view...
Fixed predictable budget vs. multiple experts with ¿ the meters running at different rates¿
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