Pharmaceutical, biotech, Medical Device and Diagnostic: FDA Regulatory IP, LCM, Litigation Support & Transaction Issues.*

Business Development Due Diligence and Acquisition Support

Each pharmaceutical, biotech, medical device and diagnostic company needs to know its business inside and out and to consider what would enhance both
its functionality and attractiveness to potential investors, licensees/licensors and/or acquirers. As tenured in-house and external legal and business advisors, Pharmidable Legal Advisors, LLC can help you formulate smart Business Development and Due Diligence plans to enhance your portfolio, provide honest, in depth and useful consideration of relevant merits and deficits of acquisition candidates and help you to polish your assets to best effect and be prepared to explain away warts and rough patches.

Patents and Intellectual Property Advice and Solutions

Pharmaceutical, biotech, medical device and diagnostic patents and intellectual property are governed by the patent rules and laws administered by the various patent offices and courts around the world. Like with regulatory law, these patent requirements pose both challenges and opportunities to your company. Pharmidable Legal Advisors, LLC’s extensive patent office, patent law and Hatch Waxman expertise can help you to design your patent and intellectual property protection through identification of new patentable subject matter, patentability and freedom to operate analysis, right-sizing your portfolio, creating your patent story and explaining the purpose and value of it to management, investors, licensees and acquirers, drafting patent licenses and other critical agreements, and leveraging your intellectual property portfolio to enhance, maintain, integrate and maximize both patent and regulatory protection and exclusivities.

Smart pharmaceutical, biotech, medical device and diagnostics companies don’t wait for litigation to materialize. They turn to knowledgeable advisors early on to immerse themselves in the company’s business to be forewarned and forearmed to anticipate and strategize around potential litigation scenarios regarding anti-trust concerns, breach of contract, Hatch Waxman, patent infringement and/or invalidity arguments, Citizen Petition process, products liability concerns, FDA regulatory audits and QA oversight, off-label promotion, ethics and anti-fraud compliance, environmental, employment and governance issues and vulnerabilities, and complex discovery issues related to each of the foregoing. Pharmidable Legal Advisors, LLC’s unique and vast experience in such matters can help both prepare your organization to address and often even avoid such risks altogether in forming your strategic approach to approval, intellectual property protection, commercialization and marketing of your products and to deal with any fallout from such processes.

Expert Witness Services and Support

Whether you anticipate, are mired in, or simply want to proactively prepare or avoid the potential for, Hatch Waxman, patent, regulatory, products liability, antitrust or other litigations, Citizen Petition processes, government investigations, or you need assistance strategizing your positions, Pharmidable Legal Advisors, LLC has significant experience as erudite and persuasive subject matter expert witnesses in litigations and can seamlessly provide the customized support you need to prepare and prevail.