Product development

How can we help strengthen your product on its journey to market?

We understand that your first objective is to enhance your science, produce solid safety and efficacy data, and bring your technology to market—and ultimately to patients—as quickly as possible. Achieving this goal involves several intensive and often concurrent efforts:

• You will need to continuously improve your technology (formulation development, in-licensing of add-on technologies, scale-up manufacturing) to prepare for clinical and commercial activities. We can support you with the drafting and negotiation of all your licensing and R&D agreements.
• You will need to design and implement a clinical program. We can support you with all regulatory questions concerning your clinical trials, the selection of your CRO and the set-up of all required documents and contracts to conduct your clinical trials. 
• You will be required to establish a robust outsourced manufacturing platform to support both clinical trials and commercial activities. We can support you with the selection of your CMOs, and the drafting and negotiation of your manufacturing agreements. 
• You will need to invest in raising the market’s awareness for your product by engaging with key opinion leaders (KOLs), establishing early access programs and disseminating scientific information. We can support you to ensure that your early access programs, interactions with HCPs and scientific communications on your drug candidate are compliant with applicable laws in Europe. 
• You will be required to build a compliant environment to satisfy the requirements (and avoid the scrutiny) of regional and local authorities. We can support you with the set-up of all your compliance policies and provide trainings to guarantee adherence with these policies.
• You will need to expand your territorial reach through local representation and workforce expansion. We can support you with the set-up of your local representations and all local employment questions in this respect. 
• You will need to craft and implement a commercial market access strategy, including obtaining marketing authorizations, securing pricing and reimbursement approvals, and setting up distribution networks. We can support you with all your local pricing and reimbursement questions and the drafting and negotiation of your distribution agreements in Europe. 

Investments & BD

How can we help you securing the right investments to drive your company's growth?

We understand that your second objective is to consistently monitor the market to secure the investments needed to fuel your growth. This can be accomplished by:

• Bringing in new investors through multiple rounds of funding
• Securing external non-dilutive funding, such as grants and subsidies

Additionally, it will be crucial to maintain your appeal to potential future acquirers and licensees of your technology. A strong product will enhance your attractiveness for regional or indication-specific out-licences, co-development projects, or the acquisition of your entire portfolio or company.

We can support you with the drafting and negotiation of your non-dilutive funding projects and your strategic out-license agreements.