Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies that develop innovative solutions to pressing public health challenges around the globe.

Greenleaf provides regulatory guidance on issues that include, but are not limited to:

	Product Lifecycle Management Strategic guidance regarding the FDA regulatory process Post-market safety requirements Assessing generic competition
	Product Approval Analyzing Complete Response Letters Preparing for FDA Advisory Committee meetings Personalized medicine and the FDA approval process
	Product Labeling Strategic guidance on new labeling requirements Strategic guidance on labeling negotiations Risk Evaluation and Mitigation Strategy (REMS) safety plans
	Manufacturing and Compliance FDA inspection process Assessment of Form 483 and EIRs Current Good Manufacturing Process (cGMP) deficiency letters Corporate warning letters
	Marketing and Promotional Practices Direct-to-consumer (DTC) advertising review process Remediation of untitled and warning letters Use of social media
	Regulatory Policy Implementation of FDA’s Follow-on Biologics program Generic drug issues FDAAA implementation FDA policies and processes FDA Advisory Committee analysis

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