The Headquarters of Rivendell International is based in Ireland, 20 minutes from Dublin airport, with modern offices in the heart of the Irish countryside.
We work with companies of all sizes, from all over the world. Our clients include major multi-nationals and small generic manufacturers. We work equally well with task forces and individual companies, and even with other consultancies.
Rivendell will conduct any type of regulatory project that is required. The following are examples of the types of service that we can provide.
- EU dossier preparation (91/414/EEC, 98/8/EC & OECD formats)
- Annex III dossier preparation
- Biological assessment dossiers
- Member State registrations
- Study commissioning / monitoring
- Task force co-ordination
- Data Gap Analysis
- Re-classification of preparations (99/45/EC)
- Risk assessments
- Advice on data protection issues
- Regulatory updates service
- Literature searches
- Advice on long-term regulatory strategy
- Representing client companies with regulatory authorities