With decades of combined experience, we are specialised on combination product development and regulatory submission. Our track record spans the entire industry spectrum—partnering with agile startups and global pharma leaders alike to deliver successful market launches
Moving a drug from a vial to a device is a challenging endeavor full of technical, manufacturing and regulatory risks. Drug-device compatibility, device design considerations and usability are often not present in-house in pharmaceutical companies, leading to underestimate the complexity of the device development process. This is especially true for 'off-the-shelf devices'. It is a common missconception to think that these devices can be placed on the market as they are, and that the device vendor is the sole responsible for the safety and effectiveness of the device.
Beyond Conception has helped numerous companies navigate this journey effectively, mitigating risks before they materialise and ensuring that the delivery device is cleared when the drug is ready to hit the market.
Often viewed as merely a convenient means of delivering the drug product, delivery devices play an extremely important role in the overall success of the treatment. The right early design choices will prevent costly budget and schedule deviations.
At Beyond Conception, we speak both languages. We are the bridge between the pharma and the device world.
As the Manufacturing Authorisation Holder, your company can't outsource accountability for the finial product. Your company must remain in control of all suppliers, which requires of product-specific expertise.
Regulatory requirements can be similar or totally different depending on the target market. Identifying these synergies and differences early on will prevent unanticipated set backs.
Packaging and usability must be addressed early to comply with regulatory requirements, stakeholder expectations and ensure patient adherence.
Regulatory considerations are integrated from the earliest stages of development, helping avoid late-stage surprises and rework.
We act as a single point of responsibility across technical, regulatory and operational dimensions, reducing fragmentation and improving alignment.
Our experience is specifically rooted in complex drug–device combination products, where interfaces, stakeholders and regulations intersect.
We focus on practical solutions and structured execution, supporting informed decision-making throughout the project journey.
At Beyond Conception, we work as an extension of our clients’ teams rather than as an external provider.
We prioritize transparency, alignment and open communication, ensuring that decisions are shared, expectations are clear and responsibilities are well defined throughout the project.
This partnership-driven approach allows us to build long-term collaborations based on trust, rigor and mutual understanding.
Dr. Uwe Goßlar
Senior Consultant, Granzer Regulatory Consulting & Services
Get in touch to discuss your project and explore how we can support you.
