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Research & Development: An Inventor’s Dream
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The inspiration for focused research and development arises from Pisgah’s manufacturing heritage. True success is best realized when commercial opportunity is consummated with an inventor’s dream to yield a product offering. The challenge today is to win the race by staying ahead of the pack. In reality, manufacturing capability alone may have no geographical consequence; conversely knowledge based manufacturing should remain tightly held in order to protect its value. At Pisgah Labs, superior API manufacturing facilities are melded with enabling intellectual property to yield a formidable market power. As the Company’s manufacturing capability and complexity has increased, the Company’s inventive spirit was also ignited to overcome the global market forces which today are driven primarily by cost. A business plan, whether for Pisgah or for a technology / product licensee, should be built on the bedrock of intellectual property and not the volatility of a cost-driven market. In today’s global economy, intellectual property is the driving engine to sustainable market share and profitability.
With these tenets in mind, Pisgah’s R&D activities are focused on final dose products wherein product protection and value is available through chemical and physical modifications to the drug substance. Furthermore, these drug substance modifications have led to discoveries for new engineered excipients and manufacturing techniques useful in providing features, advantages, and benefits to a variety of pharmaceutical products of various presentations and therapeutic category. Beginning with the API, Pisgah’s integrated approach matches the chemistries of the drug substance and the drug product with the intended performance features when administered to a patient.
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This vertical integration approach addresses a number of factors commonly required in regulatory submissions: safety, efficacy, stability, packaging compatibility, drug release profile and delivery mechanism to name a few. For each factor, Pisgah’s technology is available to support a branding strategy leading to patent protected products.
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Pisgah Labs’ current R&D initiatives will continue to focus on extending the breadth and depth of its platform technology with both strategic and tactical goals. Strategic R&D goals include expansion of Pisgah’s fundamental technology to protect and engulf huge areas of identified, but unexplored intellectual property. Tactically, Pisgah’s R&D goals are addressing specific products and product presentations which could achieve rapid market penetration. The Company’s R&D activities are generating a continuing stream of valuable intellectual property for which the company intends to license.
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