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We recommend the best regulatory pathway to market key pipeline products. Our due diligence activities assess the FDA and EU compliance of target companies. We also draft disclosures, describing for investors the FDA and EU regulatory framework and its application, and review FDA and EU-related provisions of merger, acquisition, and funding agreements. We’ll work with you and our commercial team in drafting the FDA and EU regulatory compliance aspects of supply, quality, distribution, and Own Brand Labeling agreements. Post-transaction, we assist with integration activities; transfer of ownership of marketing applications and CE Certificates of Conformity; and State licensing and EU Member States requirements for manufacturing and distribution of devices.
