Directive, Regulation & Guidance updates
In the ever changing Global Regulatory Environment, frequent updates to regulations, laws and guidance become a challenge to follow and observe. The requirement to track and comply with these updates is increasingly more demanding.
How can we help?
EUDRAC utilises a variety of technologies to conduct regular reviews of new and changing regulatory requirements for over 70 countries. These provide:
- timely alerts for clients of any new requirements for their ongoing applications and existing Marketing Authorisations
- translations for documents that are only available in local languages
We have partners in all European countries and many regions worldwide, so we are able to communicate with different Competent Authorities on specific national requirements.
Our service includes providing client-customised reports for country-specific updates in their markets and for their different therapeutic areas or drugs. Clients are able to further review any new requirements with our country partners.
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 these 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:
- 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 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 return; in addition there is always a requirement to be a competitive market player.
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 is reviewed
