Holland & Knight
Leading legal experts guiding pharma and specialty pharmacy through regulatory, reimbursement, and transactional challenges.
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Largest U.S. healthcare law practice (400+ attorneys)
Key Differentiators
- Largest U.S. healthcare law practice (400+ attorneys)
- multidisciplinary teams with in-house pharma/pharmacy experience
Overview
Holland & Knight is a global law firm providing legal counsel to pharmaceutical, biotechnology, and pharmacy companies on regulatory compliance, FDA approvals, transactions, IP, Medicare/Medicaid reimbursement, and litigation. They assist pharma firms with product lifecycle management from IND to post-market, including patient assistance programs like copay and 340B. Their pharmacy team supports specialty pharmacies, PBMs, and pharma services with licensing, contracts, compliance programs, and M&A.
Services & Capabilities
- FDA regulatory counsel (IND, NDA, BLA, expedited reviews), Medicare/Medicaid reimbursement strategies, compliance programs (AKS, Stark, Sunshine Act), IP assessment/licensing, M&A transactions, patient assistance (copay programs, 340B, rebates), pharmacy licensing/permitting, contract negotiation (P
Competitive Position
- Largest U.S. healthcare law practice (400+ attorneys)
- multidisciplinary teams with in-house pharma/pharmacy experience
- expertise in pharmacy-specific regulatory issues including specialty pharmacy and pharma services compliance.
Recent Developments
Named Health Care Practice Group of the Year (Law360 2025); USA Private Equity Law Firm of the Year (2025); top M&A rankings; advised on healthcare deals e.g. Evernorth $3.5B investment in Shields Health Solutions (specialty pharmacy), AdventHealth acquisitions.
Client & Partner Ecosystem
Sunovion Pharmaceuticals (M&A for COPD product acquisition), Elevation Pharmaceuticals, pharmacy chains, drug manufacturers, private equity firms [HK case studies](https://www.hklaw.com/en/case-studie; Advised AdventHealth, Evernorth Health Services, Conduent, Jabil, Granite Creek
Technology Platform
None
Therapeutic Focus
broad/all
Target Customers
Pharmaceutical and biotech companies, specialty pharmacies, home infusion pharmacies, PBMs, drug wholesalers/distributors, 340B entities, reimbursement hubs, prior authorization programs, financial assistance providers, pharma services companies
Sources
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