Regulatory affairs


In this regulated business, crop protection companies need to fulfil the regulations to commercialize their products. This is one of the biggest challenges that companies are facing.

Registering a product requires time and investment, but also knowledge and expertise.

Each market has its own regulation and registration procedure with different authorities involved. The process can be complex and several question marks and uncertainties arise.

Dextra has developed internal procedures that are followed to grant timing reduction and a uniform and professional working method in all markets where we are active.

We speed up the process, by splitting the process into 2 main blocks:

1. Check-list

We start the process with a Data Requirement Analysis where we analyze the technical and documentary requirements and continue with a Pre-check system where we verify the data received by our client. In less than 15 days we send a report to the client informing about the missing data and the needed actions that must be taken.

2. Registration process

With the Pre-check done, we can plan the dossier compilation based on the estimated timings of missing data and the different activities that must be conducted such as trademark registration and efficacy trials. We work since the very beginning with all the actions in parallel to avoid delays afterwards. Dextra takes care of the compilation, submission and follow-up of the dossier in front of the authorities, answering all possible remarks until the approval of the registration is granted.

We maintain permanent contact with the authorities in each country, in an ongoing monitoring system, to ensure agility and response in each of the process proceedings.

Dextra has a global reach and is active in all 5 continents. We have established an exclusive accession framework agreement to Dextra network with local consultants in many markets, assuring quality and implementation of our D360 methodology. In this way, our clients know that they will get the same service, the same information and the same reporting, independently of the market they are working in.

Dextra is the only interlocutor for a wide range of countries, facilitating our clients the follow-up of all their projects, guaranteeing same work methodology and assuring data confidentiality.
Investment in studies is huge, so working under strict security conditions is a must.

We use the highest level of security for the custody, distribution and access of documents provided by our customers, through a high encryption platform offered by the system Regulatory Disclosure of Merril Corp, and always under the European Directive 95/46/EC of data protection.