Life Sciences
Your life sciences, medical device, pharmaceutical and biotechnology (biotech) business faces unique challenges throughout every stage of its product and business life cycle.
Whether you're developing a strategy or ensuring the right controls are in place to manage risk, our specialists are here to provide the expertise to support your needs.
From regulatory changes and shifts to digital transformation, economic, political and technological forces will have a significant impact on compliance, risk management and stakeholder engagement. As the life sciences industry faces ongoing change, the ability to anticipate emerging trends is key for organizations to drive growth and mitigate risks.
Top trends
Finance transformation and operations support
Life sciences organizations of all sizes are regularly faced with navigating complex regulatory and financial landscapes. We can help ensure compliance while improving operational efficiency to reduce costs and enhance productivity, allowing you to focus on innovation. Whether your back-office functions are outsourced or performed in-house, we can help optimize your financial strategies, mitigate risks, comply with industry regulations and enhance your overall strategic position in the market.
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- Government and commercial pricing and contracting
- Life Science Jump Start
- Gross-to-net accounting in the bio-pharma industry
- Internal audit: understanding co-sourcing and outsourcing models
- The future of HR and payroll: staying compliant and mitigating risk
Risk mitigation
Life sciences companies operate in a heavily regulated environment under intense public scrutiny. To help safeguard the value of life sciences products and corporate brands, we work with our clients to ensure compliance with local, federal and international regulations, while maintaining a strong commitment to integrity. Through robust enterprise risk management (ERM), internal audit functions and System & Organization Controls (SOCs), we help minimize risk, enhance operational transparency, and strengthen overall governance.
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- Risk management guide for life sciences companies
- Biopharmaceutical company outsources compliance function to drive successful product launch
- Global pharmaceuticals company begins its ERM journey
- Enterprise risk management for life sciences companies: Navigating challenges across the organizational life cycle
Compliance and ethics
Our team of life sciences professionals provides a comprehensive set of solutions to solve your most pressing compliance and ethics needs across all facets of your organization. From compliance risk and needs assessments, compliance auditing and monitoring, quality management and pharmacovigilance to technology-enabled life sciences compliance solutions through our complianceNOW suite of products, our team can help identify and mitigate risks across your organization, establish robust auditing and monitoring programs, ensure the ongoing safety of your products and simplify tedious, repetitive tasks, so that your leaders can confidently manage navigate compliance and risk controls.
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Global spend transparency
Life sciences companies of all sizes face challenges in complying with global spend transparency reporting and regulations. Our team helps companies understand the environment of spend transparency reporting to help simplify and streamline accurate and timely compliance with reporting obligations.
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Drug price transparency
Navigate the increasingly complex state and local price transparency and reporting environment through our pricing strategy, price reporting, and transparency services. With the Inflation Reduction Act (IRA) introducing new regulatory pressures, our team provides the guidance needed to adapt to these changes while ensuring compliance and optimizing pricing strategies for long-term success.
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Embracing digitization and innovation
In an era were data drives decision-making, commitment to digitalization and innovation not only enhances operational efficiency but also supports product development and strategic planning, enabling you to navigate complex challenges with confidence and agility.
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- How AI is revolutionizing the healthcare and life sciences industry
- Disclosure management company conducts AI innovation workshop to streamline processes
- Automating the traditional KOL tiering process for life sciences companies
- Transforming Life Sciences Compliance: Baker Tilly Unveils Innovative HCP Engagement Solution
Tax and audit support
Regulatory requirements and financial transparency are paramount, your organization needs tax and audit support to stay ahead. Our proactive approach to assurance, tax planning and regulatory compliance ensures you are well-prepared for audits, IPO considerations and strategic financial decisions. With deep industry expertise and a forward-thinking mindset, we help you navigate complex financial landscapes with confidence and clarity.
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Life sciences product life cycle
At each stage of the life sciences journey, from emerging to exit, Baker Tilly provides specialized solutions to help organizations navigate regulatory, financial and operational challenges, ensuring compliance, optimizing performance and driving long-term growth.
Discover complianceNOW, a technology-driven solution suite that integrates user-friendly tools with Baker Tilly's advisory services, empowering life sciences leaders to simplify compliance tasks, enhance efficiency with embedded controls and strengthen global operations. This suite of comprehensive solutions provides a robust framework to optimize compliance programs and drive operational success.
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