Life sciences companies must adapt to succeed in the challenging financial and regulatory environment of 2023 and beyond. With investments down in most sectors, many development-stage companies may need to shift their strategic focus to operating and launching products independently. Product development challenges are also increasing for all companies, as the industry forges into novel and more difficult therapeutic areas.
To survive – and thrive – in this environment, savvy companies will need to keep a finger on the pulse of regulatory developments at all stages of the product life cycle and collaborate with trusted advisors to identify creative approaches to ensure financial stability, regulatory success, and effective compliance programs. Leveraging the strength of over 200 lawyers advising biotechs on the full scope of regulatory, compliance and enforcement, litigation, and transactions in every sector of the industry, Sidley’s Global Life Sciences team is helping companies navigate these operational challenges and opportunities, and position themselves for long-term success, including by:
- Exploring alternative liquidity options;
- Testing assumptions about global launch sequencing;
- Addressing the full range of FDA and healthcare regulatory issues that arise during the product development and marketing life cycle; and
- Developing and refining tailored compliance programs.