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Brenda Seidman and Seidman Regulatory Toxicology looks forward to help you with your FDA regulatory, toxicology, and biocompatibility issues.

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Brenda Seidman and Seidman Regulatory Toxicology looks forward to help you with your FDA regulatory, toxicology, and biocompatibility issues.

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FDA medical product consulting: regulatory, toxicology, pharmacology and biocompatibility. Combination Products (Device-Pharmaceutical, Device-Biologic, Device-HCT/Ps, Drug-Biologic). Seidman Regulatory Toxicology, LLC. Metropolitan Washington, DC Area. 2014 Seidman Regulatory Toxicology, LLC.

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Dr. Brenda Seidman, FDA consulting: devices, drug, biologics and combination products

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2014 Seidman Regulatory Toxicology, LLC. Seidman Regulatory Toxicology, LLC, launched as "Seidman Toxicology Services" in 1990, has a great deal of experience in a wide range of medical products, including medical devices, pharmaceuticals, biologics, and "combination products" - products that combine health products of different kinds:. Ells, and t. Identifying causes and offering solutions. Seidman Regulatory Toxicology, LLC.

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Seidman Regulatory Toxicology providing medical device, pharmaceuticals, biologics, and combination product consulting

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Product and Process Development. Quality Assurance and Compliance. Due Diligence of Potential Product Acquisitions. Assistance to Legal Counsel in FDA Enforcement Matters. Regulatory Strategy and Submissions. Responses to Regulatory Queries and Actions. Risk Assessment of Device Leachables and Extractables. Drug Metabolism and Pharmacokinetics. Device-Drug, Device-Biologic, Device-HCT/P, Drug-Biologic Combination Product. 2014 Seidman Regulatory Toxicology, LLC. Seidman Regulatory Toxicology, LLC.

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News and Blog. Use of ISO 10993 guidance. Article on medical device color additives.

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The Grays of Medical Device Color Additives. Food and Drug Law Journal Vol. 69 No.4 (December 2014), p 491. For a copy of this article, click here. Seidman, B. Medical Device Color Additives: What's All the Ruckus About? Volume 5, Issue 1 (January 28, 2015). For a copy of this article, click here. Seidman, B. et al. (Guest Editor and Contributor). Pure Powdered Caffeine: Stakeholders Take Measure of FDA's Warning Letters. Volume 6, Issue 1 (February 10, 2016). Old news, but nevertheless still noteworthy.

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Brenda Seidman and Seidman Regulatory Toxicology looks forward to help you with your FDA regulatory, toxicology, and biocompatibility issues.

2014 Seidman Regulatory Toxicology, LLC. Metropolitan Washington, DC Area. Seidman Regulatory Toxicology, LLC. FDA medical product consulting: regulatory, toxicology, pharmacology and biocompatibility. Combination Products (Device-Pharmaceutical, Device-Biologic, Device-HCT/Ps, Drug-Biologic).

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