FDA Regulatory and Risk Management Counseling

We provide strategic regulatory, compliance, and risk assessment and management advice to life science clients ranging from start-up biotech companies to internationally established manufacturers. Our clients include developers and manufacturers of drugs, active pharmaceutical ingredients, biologics, orphan drug and breakthrough therapies, human tissue-based products, medical devices (510(k), HDE, and PMA), radiation-emitting products, over-the-counter drugs, cosmetics, and personal care products.

Pepper understands all stages of the development process. Bringing to the table the experience of our corporate and securities lawyers, our intellectual property lawyers, and our life science litigators, we advise our clients on state and federal regulatory compliance and litigation and enforcement action risk throughout the product lifecycle. We help clients develop and implement response strategies when they face critical challenges such as advisory committee meetings, inspections, product recalls, warning letters, Form 483 citations and regulatory enforcement action. Our clients may also take advantage of our network of outside experts, including former FDA officials, GMP and quality compliance experts, and public relations firms.

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