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[Pharmaceutical competitive intelligence (CI) entails defining, gathering, analyzing, and distributing intelligence—both non-proprietary and proprietary—on pharmaceutical products, customers, competitors, and any aspect of a particular functional area needed to support executives and managers in...
[Risk-based transactions are rapidly becoming more popular methods of delivering innovative partnering solutions to customers. As a result, CROs and CSOs now add partnering solutions to their list of client options in addition to the more traditional, contract-awarded business transactions such...
[Regulatory affairs professionals are expected to provide an overall assessment of product information in the following areas: (1) US and applicable foreign regulatory affairs; (2) preclinical information; (3) clinical information; (4) CMC and Supply Chain information; and (5) commercial...
[Multiple tasks must be performed by the regulatory professional before the critical on-site due diligence meeting occurs in a private data room. Due diligence typically occurs in a secured data room format because the intellectual property (IP) is highly confidential, though, with the advent of...
[Because the intellectual property (IP) assessment is critical to determining the amount and length of protection that a product will have in a particular market/geography, a complete section is provided to address this important aspect of CI [1, 2].]
[Although every organization has its own unique process for assessing a partnering or licensing opportunity, best practice suggests that evaluation of medical technologies should include an evaluation of product, market and legal, manufacturing, and financial issues. The final due diligence...
[If trends continue, it is highly likely that regulatory professionals will become involved in one or more aspects of a due diligence process and be tasked with the identification of competitive intelligence. They will play a major role in evaluating risk-based transactions and competitive...
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