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Do you have a legal issue involving the commercialization and sale of a medical device or drug? Are you seeking to clear a medical device or approve a drug in the US Food & Drug Administration (FDA), or in international counterparts such as Europe (EMA), China (NMDA), Japan (PMDA), Health Canada, Australia (TGA), or India (DCGI)? Are you developing a reimbursement strategy so that you ensure payment for your medical device, drug, diagnostic, or other regulated product?
If so, Torrey Pines Law Group may be able to assist you. Our regulatory advisors, reimbursement specialists, and network of Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and business advisors have the experience to help you define multiple paths to market through international regulatory and reimbursement bodies. If you need a San Diego FDA regulatory advisor to help you with your international regulatory and reimbursement matters, please contact us for our free consultation to discuss your matter.
One of the many things that distinguishes Torrey Pines Law Group is our experience and ability to advise on the interaction between patent portfolio development and FDA Regulatory strategy. Our team has substantial experience with all facets of the international FDA regulatory approval and clearance processes for our San Diego clients including:
Our strategic consultations employ key knowledge in the area of FDA regulatory, clinical, product design, Quality Compliance, patent strategy, commercialization, and overall development feasibility.
Our experience with the FDA and EMA/Notified Bodies as well as regulatory agencies around the world (e.g., Health Canada, TGA-Australia, DCGI-India, PMDA-Japan, NMDA-China) provide a starting point for developing a regulatory pathway that will evolve into a full development strategy. Partnering with our clients across the development pathway is our goal while providing the nimbleness to utilize our expertise as required in a flexible and scalable model.
Our team is fluent in the languages of science, business and the law, and we are able to successfully translate between these fields into actionable strategies which impact your bottom line. Our individual practitioners have successfully advised our San Diego clients through the maze of legal and commercial issues that arise in connection with the acquisition, development, adoption, and commercialization of new technologies and IP assets in a wide range of cutting-edge industries in the United States, Europe, and Asia.
Each of our attorneys, business lawyers, and FDA regulatory advisors has many years of experience, and in some cases more than a decade of hands-on experience, with successfully developing and implementing profitable, defensible, and actionable business strategies. We understand the unique needs of our San Diego clients and provide the legal experience for every stage of growth -- from angel, seed and venture-backed startups, through IPO and early public companies, to multi-billion dollar global conglomerates.
Life sciences, Digital Health, and healthcare fields in which we help our San Diego clients include:
Our headquarters is in San Diego, California and we handle patent preparation and prosecution here for clients throughout the country, as well as international matters worldwide. If you need a San Diego FDA regulatory advisor to help you with your international FDA regulatory or compliance matters, please contact us for our complimentary initial consultation to discuss your matter.
