We understand how to navigate the sometimes tangled and easily confusing requirements of state and federal laws and regulations. We know the critical nature and importance of healthcare compliance and the vital nature of protecting personal health information. These are not small issues, and they can have a big impact on companies of any size – and we’re here to help. 

We’ve worked with pharmaceutical companies, pharma service providers, and medical device companies – at various stages of their incubation and growth. From start-up firms and emerging life science companies to pharmaceutical companies recognized among the largest in the world, we’ve worked with clients of all sizes. Among our clients are drug and medical device developers, manufacturers and distributors, and companies that service the pharmaceutical industry. Pharmaceutical companies and pharma service providers operate in a highly competitive and heavily-regulated industry; they often face distinctive and unique challenges.

At Norris McLaughlin our ample and far-reaching experience provides us with a rich tool kit, a unique lens and different perspective for meeting the legal needs of this sector.

Our services to the pharmaceutical and medical device industries include:

• General contract preparation including service, master service, project, sales, distribution and licensing agreements
• Regulatory and compliance guidance including assistance with:
  • Federal laws, rules and regulations such as FDA, the Sunshine Act, OIG Compliance Program Guidance for Pharmaceutical Manufacturers
  • The PhRMA Code on Interactions with Health Care Professionals 
  • The Federal Food, Drug and Cosmetic Act 
  • The Medicare/Medicaid Anti-Kickback Statute 
  • The Prescription Drug Marketing Act 
  • The Health Insurance Portability and Accountability Act and similar state laws, rules, and regulations
• Representation in mergers, acquisitions, reorganizations, and divestitures
• Structuring of joint ventures, collaboration relationships, and similar strategic alliances
• Work with contract sales organizations that provide sales teams, detailing services, sales force recruitment and training
• Assist companies to respond efficiently and effectively to subpoenas from the federal government and third parties
• Representation of pharma service providers in matters related to Clinical Nurse Educator and Medical Science Liaison teams, sample accountability warehousing and fulfillment, market research and data analytics
• Prepare and review clinical trial agreements (for sponsors, investigators, and monitors)
• Prepare software license agreements
• Negotiate with pharmacy benefit managers, data providers, and electronic record providers to assist with commercialization and product reimbursement
• Patent, trademark, and copyright counseling; patent and trademark clearance, opinions, filing, maintenance, prosecution
• Worldwide IP portfolio management
• Oppositions and enforcement
• Licensing negotiations and drafting in the pharmaceutical and healthcare industries
• Defense of products liability claims
• Labor and human resources guidance and employment counsel services