Acute care therapies play a crucial role in hospital settings, where fast-acting and reliable treatments are essential for managing critically ill patients. However, despite the urgent need for innovative solutions, bringing new therapies to market in this space is uniquely challenging. Strict regulatory frameworks, complex hospital procurement processes, and the high costs associated with clinical development often make commercialisation a difficult and lengthy process.

However, entering into licensing partnerships is an effective way to overcome, or at least, mitigate these barriers. By working with an experienced licensor, you can access commercially ready, clinically validated treatments without the resource-intensive demands of product development. In an increasingly complex healthcare environment, licensing partnerships are becoming a key driver in ensuring that innovative acute care therapies reach the hospitals and patients that need them most.

The acute care sector presents unique challenges that can make market entry difficult. Unlike outpatient or primary care treatments, hospitals require immediate-efficacy treatments that fit within strict procurement frameworks, stringent regulatory approval, and market access.

Beyond regulatory and market entry challenges, acute care products must also demonstrate clinical reliability in high-pressure environments. Treatments for conditions such as trauma, blood loss, or pain management must be fast-acting, easy to administer, and backed by strong clinical data to gain acceptance in hospital settings. These factors make licensing an important strategy for those seeking to commercialise acute care therapies.

Licensing allows you to bring acute care therapies to market faster, more efficiently, and with reduced risk. Instead of investing years into research, development, and navigating regulatory approvals, you can access established, clinically validated treatments that are ready for commercialisation. With the right licensing partner, you can focus on expanding access to these therapies, making the most of each other’s expertise and knowledge.

Regulatory Expertise

Navigating regulatory compliance and approvals is one of the most significant challenges in bringing acute care therapies to market. Partnering with an experienced licensor ensures you benefit from established regulatory strategies, minimising delays in market authorisation. Our regulatory affairs experts work across all areas of product development, licensing, and lifecycle maintenance, staying responsive to changes that could impact new and existing products.

Key regulatory advantages include:

• Development of tailored regulatory strategies.
• Contribution to product development programmes.
• Compilation and submission of applications for market authorisation (eCTD operational).
• Licensing guidance across multiple territories.
• Management of pre- and post-authorisation regulatory agency interactions.
• Strong experience in UK, Irish, and broader European regulatory procedures.

Market Entry & Hospital Access

Getting your therapy into hospital settings requires more than regulatory approval – it demands an understanding of procurement processes, reimbursement policies, and formulary access. Our extensive experience in market access ensures your product stands the best chance of being adopted in acute care settings.

We assist with:

• Managing submissions to national healthcare appraisal and assessment bodies.
• Collaborating with national and local payers to secure pricing and reimbursement approvals.
• Facilitating inclusion in:
  • National treatment guidelines.
  • Hospital formulary listings and protocols/pathways.
  • Area Prescribing Committees and primary care formularies.

Commercial Strategy & Sales Support

Bringing a new product into the acute care market requires a well-defined commercial strategy to maximise success.  With demonstrable sales and marketing expertise, we give licensed products the best chance of success in an increasingly competitive environment.

Our commercial strategy includes:

• Effective product differentiation through a well-informed market approach.
• Clear articulation of the product’s value proposition.
• Incisive and compelling marketing communications.
• Engagement with healthcare professionals, medicines management teams, and relevant patient groups.

Supply Chain & Distribution

Efficient distribution is critical for the continuous supply of therapies to hospitals and pharmacies. Our established distribution network covers multiple global regions, including the UK, Ireland, the Nordics, and wider Europe. We work to meet in-market demand, providing readily available licensed products where they are needed most.

Our capabilities include:

• Established relationships with wholesalers to ensure product availability.
• Shipping via trusted and authorised partners in various locations.
• Robust storage and logistics solutions to support supply chain continuity.

Licensing isn’t just about commercialisation – it’s about ensuring that hospitals and healthcare providers can access the most effective treatments sooner. As part of our mission to improve patient care, we are looking for licensees who share our goal to bring hospital-based, acute-care therapies to those who need them.

As the demand for hospital-based therapies grows, so does the need for faster, more efficient routes to market. When done successfully, licensing helps strengthen your position in the acute care space by offering established, clinically backed products in combination with expertise to overcome regulatory, market access, and distribution challenges, so that life-saving treatments reach the patients who need them most sooner. If you’re looking for a way to bring acute care therapies to hospitals more effectively, licensing could be the key to achieving your goals.

If you’d like to learn more about how licensing partnerships can bolster your market presence and portfolio, get in touch today to see how Galen can help.