
WuXi Biologics’ Biologics Manufacturing Facility, Dundalk, Ireland
In April 2018, China-based biologics services provider WuXi Biologics announced plans to construct a new biologics drug substance manufacturing facility in Dundalk, Ireland.
DOKUMEDS is a European clinical research organisation providing a comprehensive range of services for clinical research and development, as well as market licensing of pharmaceutical and biotechnology products. DOKUMEDS operates both inside and outside of the European Union, and has the immediate ability to provide services all over Europe. DOKUMEDS’ offices are located in Latvia, Lithuania, Estonia, Poland, Romania, Ukraine and Russia.
Our services include:
DOKUMEDS can undertake a range of clinical trials and studies. These include:
We can also provide a range of support services, which include:
We also provide study site management services, including pre-study preparation of study sites, initiation and monitoring. DOKUMEDS offers medical and scientific consultation throughout the study, undertaken by experienced clinical research coordinators.
DOKUMEDS provides a selection of services to aid the regulatory approval of pharmaceuticals. These include:
We also provide a selection of marketing authorisation services, including:
DOKUMEDS has developed a professional dialogue with national competent authorities, ethics committees and key opinion leaders. This national know-how ensures our ability to handle country-specific procedures, complying with local laws and requirements.
The company’s services are especially focused on regulatory consultancy and marketing authorisation handling in Russia, where clinical trials are being considered as part of marketing approval, and Ukraine.
DOKUMEDS’ pharmacovigilance services are extensive and highly professional, including:
Other services include literature search, safety profile monitoring, signal detection and review of new data, risk-benefit profile monitoring and assessment and safety database management.
DOKUMEDS can aid in the development of clinical research and pharmaceutical projects, which can include:
We can also provide scientific advice, including:
Companies can also take advantage of our lifecycle management planning and execution services, including:
DOKUMEDS’ translation services are specifically aimed at medical and pharmaceutical translations, covering a wide range of speciality materials. All translations are done by highly experienced personnel, and involve doctors, pharmacists and biologists.
Specific medical writing and translation services include:
Clinical trials logistics can be a significant challenge in an unfamiliar market. DOKUMEDS operates a warehouse in Russia and provides logistics services to meet this need:
In April 2018, China-based biologics services provider WuXi Biologics announced plans to construct a new biologics drug substance manufacturing facility in Dundalk, Ireland.
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