Directive, Regulation & Guidance updates

EUDRAC has a validated system of review for updates to different regulatory requirements in over 70 countries.

• These provide timely alerts for clients of any new requirements for their ongoing applications and existing Marketing Authorisations.
• We provide translations for documents that are only available in local languages.
• We are able to communicate with different Competent Authorities on specific national requirements.

How can we help?

EUDRAC provides regular updates on changing regulatory requirements to our clients. We also provide ad hoc reviews for specific countries, therapeutic areas and different types of drugs.

Pharmacovigilance Intelligence

The Pharmacovigilance (PV) regulatory environment is rapidly changing, with the recent updates to European Union Good Pharmacovigilance Practice and EudraVigilance. It is becoming more important keep up-to-date with regulatory changes to ensure that a Pharmacovigilance System is both compliant and efficient.

How can we help?

EUDRAC utilises a variety of technologies to conduct regular reviews of new and changing regulatory requirements for over 70 countries. We have Partners in all European countries and many regions worldwide

Our service includes:

• Monitoring EudraVigilance related updates to ensure that our processes and policies are in line with the business rules established by the EMA.
• We act as EudraVigilance Responsible Persons (RP) or the QPPV for our clients and can help them navigate the hurdle of setting up and maintaining a EudraVigilance account.
• Providing our clients with regular country-specific updates on PV requirements in their markets
• Alerting our clients to any changes that affect their PV systems and Marketing Authorisations
• Giving training on updates to PV processes, systems, coding conventions and documentation
• Providing PV support to clients to implement any required changes

Competitor Review

The review of competitors’ products can be vital for formulating the strategy of a Marketing Authorisation (MA) and can be essential for establishing a viable marketing strategy and pricing. Assessing the needs and demands of patients and consumers can also provide the information to accurately predict sales and returns. In addition, there is always a requirement to be a competitive market player especially within the pharmaceutical sector.

How can we help?

EUDRAC provides clients with up-to-date information on the status of their competitors’ drug portfolio. Furthermore, any new competitor drugs are identified at an early stage of development.

• We conduct specific reviews of regulatory and commercial changes to a client’s competitor products
• All updates to MAs are monitored from the point of submission to Regulatory Authorities
• Competitor business activities and media reports are researched
• New scientific evidence that will have a future impact on products are reviewed (e.g. for generic drugs or substances of the same class).
• Review and monitoring of publicly available clinical study reports to establish the need for a post-trial access or in cases of unmet medical need, help strategize the establishment of Expanded Access Programmes to aid in the gathering of real-world data to substantiate the MAA dossier.