Regulatory
BIOECOPEST - Regulatory
In the EU, the agroindustry is heavily regulated with the aim to ensure human, animal, and environmental safety. It means that most of the products needs to be authorized before entering the market. The authorization is granted based on the Registration dossiers submitted to the Authorities, EFSA and Member States.
Bioecopest, along with selected partners with more than 30 years’ experience in the regulatory consulting, can help you to get out of the complex environment of regulations, data requirements and technical documents, preparing the Registration Dossiers and ensuring your innovative actives and formulates will enter the market.
Bioecopest, along with selected partners with more than 30 years’ experience in the regulatory consulting, can help you to get out of the complex environment of regulations, data requirements and technical documents, preparing the Registration Dossiers and ensuring your innovative actives and formulates will enter the market.
Our services for the first approval or re-registration include:
- Project management,
- Data gap analysis,
- Coordination in producing the missing data, with our internal expertise or with selected partners,
- Preparation and submission of registration Dossiers, including BAD and National addenda,
- Waivers and expert statements preparation,
- Dialogue with the Authorities throughout the whole process, from dossier pre- to post-submission.
