Partners & Cooperations

Partners & Cooperations

PRSG is cooperating with several partners all over the world. Hereafter we present our cooperation partners:

apis labor GmbH is committed to highest quality standard (EMA,FDA). The company has two core areas, consulting and chemical testing. As the first paperless laboratory under GMP conditions in Austria, apis labor GmbH offers chemical testing of raw material, finished product and stability testing. Based on the extensive analytical experience of the entire team fast and high quality solutions can be offered to the customers. Method Development, Validations and release testing represent the daily work of the laboratory. Core competences: UHPLC, Gas chromatography, chemical and physical testing for pharmaceutical cosmetics or food supplements. As consulting company, the customer can profit from the extensive experience from qualified persons and senior consultants which assist during capacity peaks, trouble shooting or qualification of new supplier.

www.apislabor.at

Net-Translators is one of the leading medical translation companies providing translations in over 60 languages. For over 15 years, we’ve translated product-related content for regulators, customer-facing content for medical companies, and medical device manufacturers, and certified medical translations using our meticulous, quality-centered methodology. Our expertise in medical requirements enables us to help our customers navigate the requirements for each country. Net-Translators is certified to ISO 9001:2015, ISO 13485:2016 and ISO 17100:2015. Learn more about Net-Translators by visiting www.net-translators.com .

EQT corporate consulting (success through quality and transparency) offers services and consulting in the fields of management systems (quality, environment, safety, risk, health), data security (GDPR - General Data Protection Regulation) and organizational development. An efficient and transparent cooperation of high quality between the client and the EQT corporate consulting is of high importance. The portfolio ranges from the execution of individual projects to takeovers of outsourcing agendas of smaller as well as big companies. Mag.a Eva Plaschke, the managing director of this company, provides professional experience in management systems, data security, organizational development, electronic workflow systems/digitization and document management systems, which she gained by conducting various activities in executive positions for many years. The environmental scientist is not only a certified quality manager but also an auditor (repeatedly recertified) as well as a certified risk manager. She possesses extensive knowledge and qualifications concerning the diverse ISO standards and legal regulations in the fields of quality, process and risk management, GMP, MP statute, data security, GDPR, electronic workflow systems and design, and the planning and execution of organizational development processes. Since 2018 she has been a certified data security engineer as well as a certificated data security expert. Further information can be found on: www.eqt-unternehmensberatung.at

EuDRAcon provides expert knowledge and support across a wide range of Regulatory Affairs services since 2007. This is achieved through a pan-European network of independent service providers in regulatory affairs specialised in the field of medicinal products, medical devices, cosmetics and food supplements.

In order to achieve the most effective resolution of all regulatory matters, we have chosen to conduct business in a network of nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. The local presence of service providers eases the communication with regulatory authorities, aids follow-up as well as ensures the reliable management of national steps. This means that we offer quality, flexibility and cost-effectiveness across all of the services we provide for the different markets.

www.eurdacon.eu

The Research Center Pharmaceutical Engineering (RCPE) is Austria’s leading research center for pharmaceutical process and product design. With our work we support our partners to develop and pioneer novel drugs and associated production routes.

www.rcpe.at

RD&C Research, Development & Consulting GmbH is a globally acting expert office (“Ingenieurbüro”) for pharmaceutical and biotech projects based in Vienna.

Our main expertise comprises

  • Impurity and degradation profiling (expert statements, stability issues, degradation pathways, solid state degradation, stability by design, in silico mutagenicity assessments)
  • Regulatory documentation (expert statements, gap analyses, APIMF, Environmental Risk Assessment, GMP audits, Due Diligences)
  • Management of pharmaceutical development projects (drug discovery and development, MedChem, IP strategies, project management)

rdc-concepts.com