Owen Mumford Pharmaceutical Services has proven experience developing innovative solutions, extending from platform products to bespoke services for drug delivery. Specialising in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech and generics industries - our trusted medical devices are used daily in the delivery of various medications for a multitude of conditions across the globe.
Our offering includes single and multi-dose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. These innovative products are designed to meet the needs of both our pharmaceutical partners and their patients through simplicity, ease of use and improved safety and patient compliance.
With an established history of developing world-leading custom drug delivery devices, we have now extended our capabilities to produce platform products. We pride ourselves on our expertise, support and personal offering; designing products with patient needs at the forefront of mind and to simplify our partners combination product development process. Therefore, reducing complexity and risk for the pharmaceutical and biotech industry.
UniSafe® is a simple, spring-free pre-filled safety syringe for use with 1ml primary containers. The integrated safety mechanism helps to prevent needlestick injuries and ensures compliance with safer sharps regulations. UniSafe is a passive safety device with the needle retraction & shielding automatically activated when the user has fully depressed the plunger and finished their injection using the normal injection technique.
UniSafe 1ml is already commercially available as part of the UniSafe® Platform. UniSafe 2.25 for larger medication volumes will be available during 2020. UniSafe has minimal component count and is designed to work with ISO standard pre-filled syringes. The lack of a spring means there is no risk of pre-activation during transportation. In development is a reusable auto-injector based on the UniSafe 1ml which will offer the option of connectivity.
Our products are supported by our services, and we work with our partners every step of the way, supporting and guiding from initial concept stage through to taking the solution to market.
Regulatory - with over 50 successful product registrations to date, we have experience in dealing with the FDA, EMA and other regulatory bodies. In addition, over a period of many years, we have gained expertise in the regulatory complexities associated with combination products.
Using this knowledge, we can help guide the regulatory application processes by providing the necessary data, documentation and guidance to help achieve a positive outcome.
Quality - our quality ethos across the organisation helps ensure all our devices meet the rigorous standards that apply to the device, pharmaceutical and biotech industries. As such our management system is set up to ensure we are fully compliant with medical device regulations such as 21 CFR 820, ISO 13485:2016 and forthcoming MDR (medical device regulation) as well as ensuring adherence to GMP (Good Manufacturing Practise).
Human factors - Usability is key to success throughout the product development and design process. Our principal objective is to ensure that the final injection device is safe and effective for use by a diverse range of users. Owen Mumford's human factors process is fully aligned with regulatory requirements, and our user evaluation planning is conducted to provide comprehensive study data to support your product registration process.
Manufacturing - With manufacturing and packaging operations in the UK, US and Asia, we produce billions of components and assembly hundreds of millions of life changing devices each year.
We accommodate our customers' needs with our capabilities on manual and semi-automatic assembly, flexible manufacturing and fully automated production. Our clean room facilities can be utilised for manufacturing, processing and packaging when required.
Design engineering - With a long history of providing a range of devices to our pharmaceutical industry customers, innovation and technical expertise are key to our success. Our research and development department provide the critical expertise for creating the products which help patients to improve their disease management. The process starts by acquiring an in depth understanding of patient and healthcare practitioners' needs and the challenges they face during drug administration.
With more than 60 years' experience in medical devices, Owen Mumford Pharmaceutical Services is a division of Owen Mumford, with the head office located in Woodstock, If you would like to received more information contact us, go to our website at www.ompharmaservices.com or use the form below.