Regulatory Affairs with focus on Biocidal Products and its active substances

Ensus Consulting provides tailor-made Regulatory Affairs services to national and international companies or institutions. 

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, …

Why choose Ensus Consulting for your Regulatory Affairs work?

- Cost and time savings

  • We have comprehensive experience with registration processes throughout Europe, which is reflected in the low number of additional questions and requests from the involved authorisation authorities.
  • You can plan and schedule more reliably. If required, we can coordinate a customised test program for you and propose a timetable for its execution, based on our assessment of your data situation.
  • Costs and prices that are very competitive

- High flexibility

You decide on the extent to which we assist you and take some of the work off your hands. For example, we can take responsibility for the full registration process or product defense as well as specific smaller tasks.

- Quality assured

  • You get all the services you need via a single source. For some specialist parts, we work with external experts as well as institutions, specialised in toxicology, risk assessment, human exposure, etc.
  • We have several years of experience as well as extensive contacts and are intimately familiar with the applicable legal requirements.

- Full transparency

Regular exchange of information and transfer of full dossier (data sets and other files)