Ensus Consulting provides tailor-made Regulatory Affairs services to national and international companies.
1. Ensus Consulting manages all aspects of dossiers for biocidal product (BP) authorisation and active substance (AS) approval:
-
Strategic advice on biocide regulatory processes under national transitional registration schemes and the subsequent BPR dossiers after approval of the concerned AS(s);
-
Regulatory monitoring: Alerting for new or changed national and European legislation concerning biocides
-
Supported dossier types: AS approval – BP authorisation including national, mutual recognition procedures, low-risk and Union authorisation
-
Liaison with authorities
-
Selection of the evaluating Competent Authority (eCA): Union authorisation or submission of dossiers in one Member State and should mutual recognition(s) be applied for?
-
Typical dossier steps are:
-
Pre-submission meeting with CA (competent authority);
-
Determination of data requirements and survey of available data & literature / Data gap analysis;
-
Filling of data gaps by recommendation of an intelligent testing strategy (if needed);
-
Planning and monitoring of studies (if needed);
-
Dossier preparation for ASs and BPs/ Biocidal Product Families, with IUCLID 6 (International Uniform ChemicaL Information Database);
-
Dossier submission to the (Evaluating) Member State and follow-up (until approval).
-
Other services: In-house training, support for classification and labeling of biocides (CLP), renewal/re-formatting of existing dossiers, variations, renewals, …
2. Ensus Consulting manages all aspects of dossiers for plant protection products (PPP) in the EU according to the criteria provided under Regulation (EC) No. 1107/2009:
-
The plant protection products include herbicides, fungicides, insecticides, low-risk substances, etc.;
-
This service includes the preparation of dossiers for active substances (new and renewal), technical equivalence, zonal product dossiers (new, extension, renewal), etc.;
-
Ensus Consulting closely follows the latest developments and ensures that you can fully comply with your obligations.