Regulatory Approval (FDA, USDA, EPA, DEA):
Evaluate regulatory status of product approval

Submit request for orphan product designations

Obtain fast track and/or priority review status

Coordinate studies with agency, requesting protocol assessments

Negotiate with agency to secure product approval

Review labeling and advertising

Government Contracts:
Respond to RFPs and prepare grant and
contract applications

Health Care Coverage:
Submit application for coverage

Develop and implement strategies for coverage, reimbursement, and coding

Advocate for changes in existing reimbursement

Intellectual Property:
Monitor strength of IP

Identify competitors’ products as possible targets

Monitor patent landscape

Develop licensing or other distribution channels

Conclude initial IP filings

Transactions, Finance and Antitrust:
Negotiate strategic alliances and licensing agreements

Secure venture capital or mezzanine debt

Prepare public offerings

Pre-merger antitrust notification