We specialize in registration of low-risk and simplified route active substances and products. We offer the full range of services required to ensure efficient progression through the regulatory process.
- Data Gap Analysis
- Dossier writing (biological assessment & Draft regulatory reports)
- Human & environmental risk assessment
- Reasoned case (waiver) preparation – reduced or no data requirements
- Applications (preparation, submission)
- Representation & negotiation with authorities – pre-submission meetings, facilitation, applications and post-application support