Many early-stage healthtech and biotech startups aim to partner with large pharmaceutical and life sciences companies. But in a highly regulated industry, such collaborations can be challenging. To succeed, startups must demonstrate not only innovation – but also regulatory readiness, quality maturity, and a clear understanding of compliance expectations.
DayOne hosted a webinar for its current accelerator cohort and alumni, in collaboration with Entourage – a life sciences consultancy dedicated to supporting all contributors across the industry, from startups to global leaders. With a strong focus on regulatory affairs and a broad portfolio of expertise spanning development, quality, operations, and market readiness, Entourage equips organizations to grow sustainably and navigate complexity with confidence.
The session was led by Dominique Hoff, Managing Director Switzerland, supported by Kathrin Vernice (Business Development Director), Anastasia Wolf (IT & AI Systems Expert), and Simon Schulz (Regulatory Affairs Expert). Entourage, a trusted DayOne partner, shared how startups can position themselves as credible and compliant partners for collaboration with big pharma.
The key message was clear: readiness is not about bureaucracy – it’s about building trust.
Pharma and biotech partners expect control, consistency, and a mature approach to risk and quality. To build this foundation, the Entourage team presented the essential building blocks of becoming “Pharma-ready.”
1. Prioritize risk management early
Robust risk management is the first and most critical step. Startups should identify potential vulnerabilities early, assess their level of control, and define mitigation strategies. A clear, realistic remediation plan signals maturity and reliability – reassuring partners that the company can operate responsibly within regulated frameworks.
2. Establish a scalable Quality Management System (QMS)
A structured QMS is non-negotiable in regulated industries. While early-stage startups aren’t expected to have a fully developed system, a lean or phased approach can make a real difference. Demonstrating control over key processes such as change control, CAPA, documentation and SOP management builds credibility and operational discipline. A functional QMS not only supports due diligence but also lays the groundwork for sustainable growth.
3. Develop a regulatory roadmap aligned with market goals
Regulatory strategy should never be an afterthought. Misalignment between market strategy and compliance planning can delay launches or even jeopardize partnerships. Startups should map regulatory pathways early – for example, deciding whether to pursue EU MDR or FDA approval will significantly shape documentation and design control efforts. A clear roadmap ensures resources are focused and timelines remain realistic.
4. Optimize resources wisely
With limited budgets, startups need to strike the right balance between outsourcing and building internal capabilities. Selectively engaging regulatory or quality experts can accelerate progress while keeping key know-how in-house. The goal is agility – staying lean without compromising compliance.
5. Prepare a “Pharma-ready” documentation package
To streamline due diligence and investor discussions, startups should prepare a concise, standardized documentation set that demonstrates readiness. This may include quality policies, risk registers, process descriptions, and key SOPs. Such a package signals transparency, confidence, and preparedness – all factors that increase a startup’s attractiveness to potential partners.
6. Leverage networks, accelerators, and visibility
Finally, startups should make their progress visible. Engaging in accelerator programs, applying for grants, and participating in ecosystem events like DayOne’s Innovation Showcase not only boosts exposure but also helps establish trust within the life sciences community.
Three guiding principles for founders
Entourage concluded the session with three mindset principles that define successful pharma collaboration:
1. Structure builds trust. The more organized you are, the more credible you appear.
2. Prioritize strategically. Focus on what truly adds value to your goals.
3. Reflect pharma’s standards. Understand and adopt the mindset of a regulated partner.
The more structured you are, the more those companies will trust you. Structure builds trust – and trust opens doors.
Interested in learning more about how startups can become Pharma-ready? Meet Entourage and other innovators at the DayOne Innovation Showcase in Basel, December 2025.
