News > Regulatory

05th July 2016

ABHI: Brexit Update

Given the rapid developments and continued uncertainty following the recent EU referendum, ABHI has circulated an update to shape both the long-term outlook for the medical technology industry and address near-term business needs. The sector was represented at Tuesday 28th June’s business leader round table hosted by Sajid Javid MP, the Secretary of State for Business, Innovation and Skills….

24th June 2016

Orphan Drug Designation granted to Neem Biotech’s lead drug candidate for the treatment of Pseudomonas aeruginosa lung infections in CF patients

Neem Biotech’s lead candidate NX-AS-401 has recently received Orphan Drug Designation from the United States FDA for treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. This is a significant boost for the ongoing development of Neem’s flagship candidate drug substance. The outcome of an application for Orphan Drug Designation from the European Medicine…

19th May 2016

PCI Pharma Services welcomes Pieter-Jan Vos as Business Development Manager in its international sales team

Leading pharmaceutical outsourcing services provider PCI Pharma Services has announced the appointment of Pieter-Jan Vos as Business Development Manager in its International Clinical Services division, with responsibility for Germany, The Netherlands and Switzerland. As part of the established International Business Development Team, Pieter-Jan joins PCI Clinical Services to support clients with a full suite of…

10th May 2016

Expert advice from Geldards LLP: The general data protection regulation – how will businesses in the life sciences sector be affected?

The countdown to the General Data Protection Regulation 2016 (“GDPR”) has finally begun! It has now been published in the EU Official Journal and will automatically apply in all member states (without the need for national implementing legislation) from 25th May 2018. It will repeal the Data Protection Directive 1995 (“DPD”) and the national data…

09th May 2016

MHRA approval of Quay Pharma’s GMP manufacturing suites

Pharmaceutical outsourcing specialist Quay Pharma has received full MHRA approval for its newly-installed GMP manufacturing suites at its headquarters in Deeside. The new suites are part of a £3 million investment which has increased the company’s overall manufacturing capacity and enabled it to make larger batches of product in order to continue support through Phase…

14th April 2016

Drumlord: Stronger, Better, Faster, Cheaper

The last few months of 2015 saw MediWales member Drumlord develop its SLA Department through investment in software, productivity improvements and cost restructuring. This has enabled the company to offer its Somos Watershed XC11122 SLA at greatly reduced prices.  Depending on the size and geometry of parts, the company has been able to generate savings of up to 50%…

06th April 2016

THAY Medical gains ISO 13485 and ISO 9001 certification

THAY Medical has recently achieved the first of many steps to becoming a world-class innovator of medical devices in achieving ISO 13485 and ISO 9001 certification. Since incorporating late in 2014, THAY Medical has grown based upon a core competence of human factors engineering focusing on medical devices and drug delivery products. Greg Thay, Managing…

04th December 2015

UK HealthTech reaches new heights

UK HealthTech opened its doors for the fourth time on 1st December at the St David’s Hotel and Spa in Cardiff. The conference was delivered by MediWales and attracted hundreds of professionals, clinicians and industry specialists from around the world. The programme was comprised of two parallel seminar streams; MedTech and BioPharma, and included an essential…

24th July 2015

New bench-top clinical chemistry analyzer launched by EKF Diagnostics at AACC 2015

EKF Diagnostics, the global in vitro diagnostics company, announces the international launch of the Altair™ 240 clinical chemistry analyzer at the American Association for Clinical Chemistry’s (AACC) Annual Meeting and Clinical Lab Expo in Atlanta, Ga, 26-30 July. This new bench-top platform represents EKF Diagnostics’ first fully integrated chemistry system designed for the global market….

14th July 2015

Sharp Packaging Solutions white paper on ‘Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety’

Sharp Packaging Solutions, part of UDG Healthcare plc (LON: UDG), the leading international provider of healthcare services, has launched an informative white paper on the challenges around serialisation titled “Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety”. Counterfeiting and product diversion are major problems faced by the global pharmaceutical industry. In 2007, the World…