For further information regarding our Drug Development Strategy offerings
Please contact:
Michael K. O’Brien, PhD | 860-207-8135
[email protected]
CASE STUDY – R&D Idea to Registration Framework
Situation
A rapidly expanding global biological solutions company aspired to develop an ideation to registration framework to accelerate product development from R&D to registration and commercialization. Commercial and technical resources were being added in multiple countries with minimal awareness of other products being developed outside their specific country/region.
Solution
Our NGT principal led an international team to define an end-to-end process that integrated R&D, regulatory, operations, manufacturing, marketing, sales and IP protection.
Market and customer feedback loops were established at each development stage gate to address changes within regulatory and other external factors.
Tools were designed to capture key technical, market and financial information essential to the success of new product development and commercialization in strategic market segments and a reward and recognition system was developed to build engagement, acknowledge achievements, stage gate advancements and first sales, and to create awareness amongst colleagues and leaders globally.
Impact
Improved lab to marketplace connection and well-defined product concepts with customer-validated key competitive advantages.
Improved cycle times from one stage gate to the next.
Transformed individual country/regional silos into efficient global network recognizing that common country-specific product concepts could be more efficiently developed under a globally integrated framework.
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