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FDA Legal Services -- for the life of a Life Sciences company
For any Life Sciences company, the nature of the critical issues they will face that arise out of the laws and regulations enforced by FDA will relate
directly to where the client stands in its own legal life cycle. For the start-up, FDA concerns may seem years off. However, they can be very real
relative to securing financing as astute investors will require validation of your FDA strategy. For the established firm with marketed products, FDA
legal challenges can take on a myriad of aspects, with concerns ranging from ensuring advertising and marketing efforts comply with both FDA and
other federal/state requirements to protecting market share through line extensions or legitimate uses of market exclusivity under the Waxman-Hatch
or Orphan Drug Acts. We are poised to provide you these critical legal services to overcome FDA's challenging and multi-faceted hurdles for the life
of your Life Sciences company.
directly to where the client stands in its own legal life cycle. For the start-up, FDA concerns may seem years off. However, they can be very real
relative to securing financing as astute investors will require validation of your FDA strategy. For the established firm with marketed products, FDA
legal challenges can take on a myriad of aspects, with concerns ranging from ensuring advertising and marketing efforts comply with both FDA and
other federal/state requirements to protecting market share through line extensions or legitimate uses of market exclusivity under the Waxman-Hatch
or Orphan Drug Acts. We are poised to provide you these critical legal services to overcome FDA's challenging and multi-faceted hurdles for the life
of your Life Sciences company.
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The lists of services included on this website are intended to be fairly comprehensive. We hope these will help you focus
on how we can assist you achieve those critical business goals that any FDA-regulated company faces in its life cycle, no
matter where you stand today. And, if your need for FDA legal counsel does not appear to fit into any of these categories
of services, please feel free to contact us and we can discuss how to best resolve your FDA legal requirements, even if that
means an occasional referral to another practitioner if your concerns are outside our usual practice arenas.
on how we can assist you achieve those critical business goals that any FDA-regulated company faces in its life cycle, no
matter where you stand today. And, if your need for FDA legal counsel does not appear to fit into any of these categories
of services, please feel free to contact us and we can discuss how to best resolve your FDA legal requirements, even if that
means an occasional referral to another practitioner if your concerns are outside our usual practice arenas.
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