The EUDRAC team have partners in all European Union countries and other regulatory regions. We undertake specialist work for our clients and liaise with the regulatory authorities and other agencies in the local language. Our approach is innovative and we have wide-ranging expertise covering many activities associated with marketing and supply chain.
A Wholesale Dealer Licence is required for the sale or supply of authorised medicinal products to anyone other than the patient using the medicine. This licence allows the holder to buy and sell or distribute medicinal products within the EU.
EUDRAC supports its clients with Wholesale Dealer Licence applications and ensure compliance with Good Distribution Practice (GDP).
The EUDRAC team are highly experienced in Wholesale Dealer Licence application:
Organisations responsible for the distribution and storage of pharmaceutical products must implement a suitable QMS to ensure that quality and safety requirements are met. A QMS must take into account all applicable guidelines and regulations on quality policy and risk management.
Standard Operating Procedures (SOP) and Work Instructions are, therefore, necessary to establish and implement the best practices that are necessary to meet the strict regulatory requirements of the industry.
Training is one of the vectors of development that should not be neglected either for companies or for employees. Both parties are winners since the company will have rewarding performance and employees can develop and update their skills.
EUDRAC provide training to different clients on aspects of both Regulatory Affairs and Pharmacovigilance. All training is customised towards our clients’ portfolios and is delivered using a variety of different media.
EUDRAC has partners in all European Union countries and also in other regions. We are able to provide advice or more formal training on even very specialist areas of pharmaceutical regulation.
The “exploitant” activities include wholesale and distribution of medicinal products, advertising, scientific and medical information, pharmacovigilance, batch followup, and if required, recall operations, as well as the corresponding storage activities (R. 5124-2, 3° of the French public health code).
The “exploitant” application dossier is assessed by the ANSM and, if it is considered unsatisfactory, this will lead to a delay or refusal of the authorisation.
The team in EUDRAC France provide guidance regarding the presentation of the “exploitant” licence application and the composition of the dossier, review and conduct “Exploitant” applications for our clients; they have a thorough knowledge and experience of the specific national requirements for all “Exploitant” activities and ensure successful applications.
The team also support clients in establishing their QA requirements and writing the necessary SOPs
Organisations responsible for the distribution and storage of pharmaceutical products must implement a Quality Management System (QMS) to ensure the required quality and safety of its products within these elements of the supply chain. A robust QMS must take into account all applicable guidelines and regulations on quality and risk management.
A QMS incorporating good Standard Operating Procedures and Work Instructions is vital for an organisation with pharmaceutical quality requirements. The Pharmaceutical Industry has strict regulations and so it is necessary to ensure that all employees are working according to best practices.
The EUDRAC team works with its clients to establish a QMS and write the necessary controlled documents. It trains employees on all aspects of the QMS relevant to its organisation.
The team have many years of experience and are involved in the development of stand-alone QM Systems for Wholesale Dealers, as well as reviewing and updating established QMS systems. -
The “exploitant” activities include wholesale and distribution of medicinal products, advertising, scientific and medical information, pharmacovigilance, batch follow up, and if required, recall operations, as well as the corresponding storage activities (R. 5124-2, 3° of the French public health code).
The “exploitant” application dossier is assessed by the ANSM and, if it is considered unsatisfactory, this will lead to a delay or refusal of the authorisation.
The team in EUDRAC France provide guidance regarding the presentation of the “exploitant” licence application and the composition of the dossier, review and conduct “Exploitant” applications for our clients; they have a thorough knowledge and experience of the specific national requirements for all “Exploitant” activities and ensure successful applications.
The team also support clients in establishing their QA requirements and writing the necessary SOPs
Quality Management Systems, Standard Operating Procedures and Work Instructions are all necessary to ensure that an organisation operates in compliance with PV requirements. Due to the strict regulatory nature of the industry, best practices need to be established, documented and implemented.
EUDRAC works with clients to provide a suitable QMS and controlled documents for their medicinal products; we also provide training to ensure that these are operated in compliance with PV requirements.
Training is one of the vectors of development that should not be neglected either for companies or for employees. Both parties are winners since the company will have rewarding performance and employees can develop and update their skills.
EUDRAC provide training to different clients on aspects of both Regulatory Affairs and Pharmacovigilance. All training is customised towards our clients’ portfolios and is delivered using a variety of different media.
EUDRAC has Partners in all EU countries and also in other regions. We are able to provide advice or more formal training on even very specialist areas of Pharmaceutical regulation.
It is a legal requirement that pharmacovigilance professionals are trained in the regulations and best practices of pharmacovigilance ; they should have suitable knowledge and experience to set up and maintain a compliant and efficient pharmacovigilance system.
The EUDRAC pharmacovigilance team is led by two Qualified Person for Pharmacovigilance (QPPV) and comprises qualified personnel with many years of pharmacovigilance experience in the pharmaceutical and medical device industry; we conduct customised training for our clients and also conduct regular pharmacovigilance intelligence updates. We ensure that both our own company and our clients are constantly up-to-date with all changes in the pharmacovigilance requirements.
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