FOCUSSED ON SUCCESS
Specialist Services
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.
Specialist Services
Wholesale Dealer Licence applications
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 export to third countries and also import medicines into the EU in order to export to third countries.
EUDRAC supports its clients with Wholesale Dealer Licence applications and ensure compliance with Good Distribution Practice (GDP).
How can we help?
The EUDRAC team are highly experienced in Wholesale Dealer Licence application:
- We support our clients in preparing and processing all required documentation for the complete application
- We also organise and maintain the full Quality Management System (QMS) and ensure our clients are duly prepared for authority inspections; we carry out training activities for GDP and also write and maintain SOPs
- EUDRAC experienced staff act as the Responsible Person for wholesale, participate in authority inspections and prepare responses to inspection reports.
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QMS & SOP development
ToggleOrganisations 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.
How can we help?
- EUDRAC has extensive knowledge of the pharmaceutical regulations, guidance and best practices that are applicable to a QMS. We operate a Regulatory Intelligence Service that ensures all updates and any new requirements are notified to our clients on a regular basis.
- We also have wide-ranging experience in creating suitable QM Systems and controlled documents for our clients to ensure efficient and comprehensive compliance with quality and safety requirements.
- The EUDRAC team undertake the development of stand-alone QM-Systems for Wholesale Dealer as well as QM-systems intended to be embedded in an overall corporate Quality Management-System.
Training
ToggleTraining 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.
How can we help?
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.
Exploitant application - France
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.
How can we help?
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
QMS & SOP development
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.
How can we help?
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. -
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Exploitant application
ToggleThe “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.
How can we help?
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
Pharmacovigilance Support QMS and SOP development
ToggleQuality 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.
How can we help?
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
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.
How can we help?
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.
Find out more about ...
Pharmacovigilance Training
ToggleIt 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.
How can we help?
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.