Regulatory Compliance (FDA, USDA, EPA, DEA):
Review labeling and advertising

Crisis management (recall and enforcement actions)

Prepare supplements for new indications or changes

Conduct due diligence audits of potential acquisitions

Phase IV trials

Coordinate appropriate adverse event reporting

Government Contracts:
Debarment proceedings

Government investigations and administrative hearings

Government Relations:
Work for coverage and reimbursement changes

Develop and implement legislative strategies

Advocate positions in administrative proceedings

Health Care Coverage:
Defend against government investigations and pricing and marketing claims

Conduct compliance audits and health care due diligence

Intellectual Property:
Monitor patent landscape and competitors’ products

Continue to police for IP infringements

International Trade:
Respond to Customs challenges

Defend against and pursue fair trade challenges

Litigation:
Defend against:
-administrative, civil and criminal enforcement actions
-product liability lawsuits
-False Claims Act/qui tam actions

Litigate:
-Tariff Act and other import/export issues
-Commercial and contractual disputes
-IP infringements

Transactions, Finance and Antitrust:
Negotiate sale/purchase of product or company

Monitor activity as market share grows

Prepare Secondary offerings