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Veteran FDA Attorney Launches Boutique Life Sciences Law Firm, Asebey Life Science Law

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Comprehensive Legal Solutions and Expert Regulatory Guidance

Asebey Life Science Law is a boutique law firm specializing in FDA regulatory compliance, transactional law, and advisory services for the life sciences industry.

Our Firm

FDA Regulatory Opinions

We assist FDA-regulated companies in determining the correct pathway for their innovative products, having provided regulatory opinions on: biosimilar biological products; compliance for products containing cannabinoids; compounded GLP-1 substances for research use; and beverages with novel botanical ingredients.

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FDA Warning Letters & 483’s

Whether you have received an FDA Warning Letter or a post-inspection Form 483, our attorneys can assist you in responding substantively and effectively by investigating the alleged deficiencies, developing a corrective and preventive action (CAPA) plan, and represent you before the FDA to seek a Close Out Letter.

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Removal from FDA Import Alert

If your company is on the Red List of an Import Alert, all associated goods are subject to CBP detention without physical examination (DWPE), jeopardizing your supply chain and reputation. Our attorneys will petition the FDA for removal from Import Alert.

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Labeling & Advertising Compliance

Whether you work with food & beverages, dietary supplements, or hemp products, we ensure your product's compliance with all federal labeling requirements, including supplement facts, structure/function claims, and allergen disclosures. We also ensure compliance with state-specific requirements.

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FDA Regulatory & Compliance Law Firm

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Our Firm

At Asebey Life Science Law, we combine deep scientific knowledge with comprehensive legal expertise to deliver effective regulatory guidance. Our objective is to turn complex challenges into clear, actionable strategies, empowering our clients with innovative solutions to navigate the intricacies of FDA regulations and legal hurdles with confidence.

Edgar J. Asebey, Esq.

Managing Partner
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Guilherme Ferrari Faviero, M.S., MPH

Research Associate
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Our lawyers can represent you in federal or state regulatory enforcement actions.

Business Transactions

  • Licensing Agreements
  • Asset Purchase/Sale Agreements
  • Distribution Agreements
  • Operating Agreements
  • Corporate Transactions
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International Trade

  • CBP Import Compliance
  • Removal from FDA Import Alert
  • Custom Detentions/Entry Denials
  • Liquidated Damages Petitions
  • Preparation for Audits
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Regulatory Clearences

  • Licensing strategy
  • NDAs, ANDA, 505(b)(2) submissions
  • Pre-IND meeting preparation
  • IND Submission to FDA
  • 510(k) & PMA submissions to FDA
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Enforcement Defence

  • Warning Letters and 483 Responses
  • Removal from Import Alert
  • Prop 65 Defense
  • Recalls and Crisis Management
  • Corrective and Preventive Actions (CAPA)
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Navigating FDA Regulations: Key Insights and Updates for Compliance Success

Stay informed on the latest FDA regulations, compliance tips, and industry updates to ensure your business meets all necessary standards and requirements.

Asebey Life Science Law is a boutique law firm specializing in FDA regulatory compliance, transactional law, and advisory services for the life sciences industry.

501 E Las Olas Blvd. | Suite 300
Fort Lauderdale, FL 33301

Available by appointment only *