Plant Protection Projects SARL – Regulatory Affairs and Registration
The PPP consultants have extensive regulatory experience and a track record of successful product approvals at country and EU level. Examples include:
- Providing expert strategic regulatory advice
- Preparing, submitting and following ADE (trial permit) applications
- Evaluating registerability and identification of data gaps
- Negotiating with national and EU authorities on behalf of the client
- Preparing regulatory project plans
- Placing and monitoring regulatory studies with CRO’s
- Reviewing study results and draft reports with clients before finalisation
- Conducting human and environmental risk assessments
- Writing OECD (EU) formatted summaries
- Preparing both the biological and toxicological dossiers
- Submitting and following-up of dossiers with regulators
- Addressing issues or questions that arise during the review process.
- Providing product defense and general regulatory support for all clients requirements
