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Our approach to business is very simple – Together Everyone Achieves More (TEAM).
At PDS we adopt this philosophy to all aspects of our business, whether it’s in relation to our internal performance, working with technology companies, other service providers, or in adding value to our clients.
Working together with our clients’ own internal resources, PDS provides an integrated extension to their operations, whilst nurturing a cohesive team culture supported by impeccable standards of quality and customer service.
Our own highly experienced drug safety and medical professionals aim to complement each clients’ internal team to deliver excellence, whilst being proactive in keeping them informed of any legislative changes, providing critical objective insights and assurance that their pharmacovigilance responsibilities and obligations are being met at all times.
Partnerships are an invaluable asset to the development of our industry and as more and more rigorous legislative changes are imposed (such as ISO IDMP) it becomes ever more critical to remain focused and on-point in relation to understanding the latest regulatory and technology developments.
At PDS we ensure our team of experienced professionals is fully trained in the latest regulations and industry standards, and we are vigilant in choosing partners who have an equally proactive and committed approach to quality standards and customer service.
Saidia Pharma Services Ltd.
Saidia Pharma Services has been our partner located in Germany for many years now. This is our link to the continent for regulatory affairs and quality assurance. PDS and Saidia can support you with liaising with BfArM, P.E.I. and local German authorities, translations, submissions and all matters involving Germany and Austria.
With the main focus in Regulatory Affairs and submission to all European authorities. (CP, MRP, DCP and national procedures), Saidia Pharma also has a vast experience in Quality Assurance (Inspections, Quality Management Systems – SOPs, deviations, quality management review), user-testing and text updates.
IPERION® is a Dutch based company with over 10 years of experience in the life sciences industry. Focus points are IDMP consultancy and RA operations support, ERP and Quality Management Systems implementation and IT services-GxP cloud computing for life sciences.
PDS has partnered with IPERION in order to understand the impact IDMP will have on our clients and moreover ensure a solution is found that fits with their situation. Furthermore, companies need to take a hands on approach in addressing the concerns and the broader perspectives of IDMP.
PDS and IPERION can you set up the necessary processes in your organization that give you benefits, next to achieving timely IDMP compliance.
Medilink UK is a national health technology business support organisation, with a strong track record in increasing the viability of manufacturers, service providers, designers, OEMs and suppliers of medical technology.
The team in Nottingham have worked collaboratively with PDS since 2011, providing support and advice to maximise opportunities. As the Life Science Industry Association we are proud to continue to work alongside PDS on their journey by delivering a series of events in partnership with PDS.
Assured Information Systems
Assured is a leading supplier of workflow-driven pharmacovigilance software to the pharmaceutical industry. The company’s software products – PV-Works and PV247 (for human and veterinary medicines) are recognised as high quality products and are specifically designed to be operated in compliance with ISO 9001 :2015 and the world-wide regulatory legislation that governs this industry.
Since June 2014, Assured is part of Ennov Group as Pharmacovigilance Division. Ennov designs, develops and distributes EDM and workflow software for the life sciences industry. The Ennov solution encompasses 4 main areas: Clinical Trials, Regulatory Affairs, Pharmacovigilance and Quality.
Ennov solutions are used around the world by +550 clients and +250 000 individual users at hundreds of sites including : AB Sciences, Abeona, Boehringer Ingelheim, IDT Biologika, Merial, MSD, Novartis, Prostrakan Ltd, Safety Call, Sagent, Smith & Nephew, Romark Lab …
PDS and Ennov have been working together since early 2016 with the purpose of providing our clients with the best services possible, from a qualitative as well as a financial perspective.