RSSL is to support manufacturers of medical devices with analytical services that will smooth the process of gaining regulatory approval for products
Reading Scientific Services Ltd (RSSL) is expanding its support to manufacturers of medical devices with analytical services that will smooth the process of gaining regulatory approval for products. Aimed primarily at manufacturers of drug delivery systems, such as pre-filled syringes, catheters, vials, closures, inhalers and intravenous devices. RSSL may also assist manufacturers in other areas to address issues around safety and stability.
RSSL's service will effectively provide a comprehensive and bespoke testing service (biological, chemical and physical) providing results for QC release, EU import certificates, affirming medical device functionality and determining product shelf-life. RSSL can also provide analytical support for scale-up and commercialisation, assess the impact of formulation changes and investigate process incompatibilities and complaints from patients/users.
Already a well-established CRO partner for many customers in the pharmaceutical industry, RSSL is GMP compliant and UKAS accredited, and offers expertise in a wide range of scientific disciplines. These include detecting and identifying sub-visible particles, performing chemical, structural and physical characterisation, high resolution imaging, carrying out studies for extractables and leachables or endotoxin analysis. RSSL's scientists support customers with routine application of pharmacopoeial methods, are experienced in method development/validation and also provide a trouble-shooting/problem solving service.
'The industry drive to innovate and deliver new drug delivery systems which are aligned to advancements in surgical and treatment is appreciable, making medical devices one of the fastest growing sectors in the pharmaceutical market,' said Alex Blanchard, Head of RSSL's Microscopy laboratory. 'RSSL's high-tech facilities are well placed to support customers with a range of sophisticated analytical tests that will assist manufacturers in ensuring that their products meet appropriate quality standards and are fit for purpose.
'For novel applications or innovative devices, we can work with customers to develop new methods as appropriate.'