Pushing the boundaries of science and technology, staying focused on innovations.
At Broughton, we understand that the field of inhalation drug delivery is rapidly evolving. Ensuring a formulation and/or inhalation device are performing to be efficient, efficacious and aligned with regulatory requirements is necessary for success.
Our team with deep industry knowledge in inhalation device development is confident that we can help you find a solution to ensure that your molecule can be effectively delivered through inhalation.
Our strength is in integrated product development, scientific substantiation, and regulatory consultancy teams working together to find the right solution for your molecule.
Whether you have a prototype product that you have already developed, or have an idea, and want to see it realized into a device, our team is here to help.
Our scientific and regulatory consultants understand what regulators are looking for in the approval of novel inhalation devices and formulations, therefore, their input is integral to the start of any product development project. Their knowledge and insights are the guiding stars for our product development team, ensuring that regulatory concerns and requirements are always kept at the forefront of product development.
Our principle for the development or optimization of your prototype is Quality by Design. At the beginning of our collaboration, we will define a Target Product Profile (TPP) aligned with the efficacy you would like to demonstrate and the appropriate regulatory requirements. Through rapid development and high throughput testing using our in-house laboratory services team, we can quickly generate feedback on the performance of the product, allowing for rapid development iterations to reach the defined TPP quickly. When your product is performing as expected, it will give confidence in investing in the further studies needed to achieve regulatory success.
Our Product Development Services team has vast experience across many industries, giving you confidence that no matter what challenges your product faces, our team will find a bespoke solution to drive the product forward.
Once your product has reached the final stage of development, our team of scientific and regulatory consultants will guide you through every step of the regulatory submission process. Our experts design and conduct the required assessments, ranging from laboratory testing to desk-based assessments. Our consultants are experts' in using this data to create narratives to support novel product regulatory submissions and provide regulators with confidence that your product will improve societal health. Learn more about our regulatory and scientific consultancy.
Broughton offers a fully integrated scientific and regulatory consultancy, combined with comprehensive laboratory services, across the nicotine, cannabinoids, and pharmaceuticals industries.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.