An experienced ally immersed in the business of health
Decisive. Creative. Fluent in mitigating risk.
Having worked both in-house with Amgen and as outside counsel with a variety of clients, I have a keen ability to translate how evolving health laws and regulations impact your business in your language without the legal jargon.
Beyond the advice, I create a roadmap and help operationalize legal guidance throughout your business. I’ll right-size it based on your business structure and resources and educate your team on industry best practices along the way.
JULIE A. PALUCH
Founder and Principal
310.463.1391 | firstname.lastname@example.org
Strategic legal solutions that help
fuel your business growth
Guiding your leadership team every step of the way to manage risk,
I consider what regulators require along with business realities.
With a deep understanding of your industry, you get high-level expertise and counsel focused on your big-picture business goals, not legal advice in a vacuum.
Counsel on a wide mix of legal, business and operational issues and compliance matters
Serve as an extension of your executive team or support your in-house counsel
Advise on matters regulated by government agencies
Strategic counsel throughout product life cycle
+ compliance support
Advise executives and their R&D and commercial business teams across the entire product life cycle to help the business navigate a heavily regulated environment, identify potential roadblocks and creatively approach issues to successfully develop and commercialize life science products.
Serve as an extension of your executive team to help define business strategy while spotting and managing legal risk, solve problems and help you make well-informed business decisions
Business development, licensing, asset purchase, co-development and co-promote relationships, and advising on exit strategy
Assist operations teams in establishing supply chain and clinical trial infrastructure
Identify and overcome obstacles to a successful launch of your product
Operationalize/implement legal strategies working cross-functionally and managing resource utilization with your business teams
Contracts & Agreements
Advise on contract management strategies and infrastructure for growing companies
Skilled drafting and negotiation of business contracts with vendors/entities used by teams throughout the business enterprise
Clinical trial programs - CTAs, ICFs, investigator brochures, patient brochures, clinical trial advertisement materials
Supply chain agreements, including contract development and manufacturing agreements
Business development agreements - licensing, asset purchases, and data purchasing/licensing agreements
Guidance on brand, marketing and sales strategies, tactics and materials to bring your product to market
Partner with brand teams on marketing strategies and tactics
Support field personnel to conduct interactions with HCPs effectively and compliantly
Participate on cross-functional teams to review and approve marketing and sales materials
Bring to light why certain things may trigger outside inquiry and how we can move forward on a path with less risk
Develop right-sized compliance department based on stage of development
Create policies and procedures and provide trainings, audit/monitoring plans, promotional materials review
Focus on documentation and provide support during internal or external compliance audits, government inquiry or investigation
Coordinate on crisis management, identify and manage experts to pinpoint advice needed to avoid wasted time and resources
Revenue strategies, including value-based care + compliance support
Work with providers transforming the healthcare delivery system on implementing value-based care initiatives and dynamic reimbursement structures to deliver on the triple-aim.
Business Strategy & Agreements
Advise on revenue strategy and negotiate complex payor agreements, including those with emerging alternative payment models and new methods of population management
Innovative contracting that focuses on rewarding outcomes-based care
Assist healthcare systems and medical groups in creating provider networks through developing contracting strategy and identifying efficiencies for operational resource utilization
Assist hospitals with research and pharmaceutical management programs, including assisting with 340B program compliance
Develop right-sized ethics compliance departments that are manageable. Work to operationalize compliance in business teams.
Work cross functionally with business teams to operationalize compliance requirements
Support through internal or external government compliance audits or investigations
Advise on, draft and revise written responses to government inquiries