Owen Mumford Pharmaceutical Services

These are designed and known for their ease of use, simplicity and improved safety and patient compliance, meeting the needs of both our pharmaceutical partners and their patients.

Platform and custom injectable drug delivery systems

With an established history of developing world-leading custom devices, we have recently extended our capabilities to include a range of platform products. We continue to pride ourselves on our expertise, support and personal offering; designing products with patient needs at the forefront of the mind and simplifying our partners’ combination product development process.

UniSafe^® pre-filled safety syringe

A simple, spring-free pre-filled safety syringe for use with 1mL primary containers, UniSafe has an integrated safety mechanism that helps to prevent needlestick injuries and complies with safer sharps regulations. UniSafe is a passive safety device whereby needle retraction and shielding is automatically activated when the user has fully depressed the plunger and finished their injection using a normal injection technique. It has a minimal component count and is designed to work with ISO standard pre-filled syringes. The lack of spring means there is no risk of pre-activation during transportation.

UniSafe platform for injectable drug delivery systems

The UniSafe platform is developed around the already commercially available UniSafe 1mL device.

UniSafe 2.25 for larger medication volumes will be available during 2020 and in development currently is also a reusable Auto-Injector, which will offer the option of connectivity.

Our services

Our products are supported by our services, working with our partners every step of the way to support and guide them from initial concept through to taking the solution to the market.

Regulatory

With over 50 product registrations to date, we have experience in dealing with the FDA, EMA and other regulatory bodies. In addition to this, we have gained expertise in the regulatory complexities associated with combination products over a period of many years.

Using this knowledge, we can guide the regulatory application processes by providing the necessary data, documentation & guidance to help you achieve a positive outcome.

Quality

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).

Our quality ethos across the organisation helps us ensure that all of our devices meet the rigorous standards that apply to the device, pharmaceutical and biotech industries.

Human factors

Our primary objective is to ensure that the final device is safe and effective for use by a diverse range of users. Usability is key to success throughout both the product development & design process.  Our human factors process is fully compliant with regulatory requirements, and we conduct user evaluation planning to provide comprehensive study data to support your product registration process.

Manufacturing

We produce billions of components and assemble hundreds of millions of life-changing devices each year through our manufacturing and packaging operations in the UK, US and Asia.

Cur capabilities include manual and semi-automatic assembly, flexible manufacturing and fully automated production. Our cleanroom facilities can also be utilised for manufacturing, processing and packaging when required, accommodating all our customers’ needs.

Design engineering

Our pharmaceutical industry customers, innovation and technical expertise are key to our success. With a long history of providing a range of devices, our research and development department provides the critical expertise for creating products that help patients to improve their disease management.

We start this process by acquiring an in-depth understanding of patient and healthcare practitioners’ needs and the challenges they face during drug administration.