Regulatory Affairs

The department

For over 15 years now, Promo-Vert has been offering its know-how and experience in Regulatory Affairs for the registration of your products.

You need advises in Regulatory Affairs, our specialists in agronomy and toxicology are at your disposal for:

– your Plant Protection Products (Chemicals & microorganisms), Regulation 1107/2009/EC,
– your Adjuvants / Safeners / Synergists (Regulation 1107/2009/EC),
– your Fertilisers and growing media (FGM), Regulation 2003/2003/EC.

Promo-Vert Regulatory Affairs assists you in:

– the definition and the management of your projects,
– the preparation, submission and follow-up of your dossiers in EU.

Promo-Vert Regulatory Affairs offers you a turnkey service (feasibility, cost and milestones) or a custom service!

Project management

Promo-Vert Regulatory Affairs assists you in defining your project, selecting the uses (market profitability), the target Member States and zones (North, Centre, and South).

Promo-Vert Regulatory Affairs performs a data gap analysis and if needed, manages a reliable and cost-effective programme in well-known and recognized laboratories (GLP).

Promo-Vert Regulatory Affairs can monitor all the needed studies and assist you from the quotation to the final report.

For the efficacy / selectivity trials (GEP accreditation) and the residue studies (GLP accreditation), our experts (project manager or study director) have direct relationships with our Principle Investigators and Field Trialists.

Dossier preparation

Promo-Vert Regulatory Affairs can prepare the dossiers for:

– the active substances (specifications, annexe II),
– the phytopharmaceutical products (dRR + BAD),
– the mutual recognition process,
– the adjuvants / synergists / safeners (risk and efficacy),
– the fertilizers and biostimulants,
– the Experimental Use Permits and all the administrative dossiers.

Promo-Vert Regulatory Affairs can write all the sections of the dossiers, preparing the study summaries and:

– assessing the risk to human health, operators, bystanders, residents and workers as well as consumers (including MRL proposals),
– modelling the fate of active substances and/or relevant metabolite(s) in the environment (FOCUS…),
– evaluating the risk to non-target organisms.

Likewise, Promo-Vert Regulatory Affairs can assist you in writing labels, MSDS…

Regulatory advices

For any questions / information, please contact directly our specialists:

Philippe FOURNIER

Toxicology/Residue
Tel : +33 559 33 34 27
E-mail : philippe.fournier@promovert.com