Scientific and Regulatory Consulting for registrations of plant protection products, bioprotectants and fertilizers.

Agrexis AG

Basel (CH) · Singapore (SG)New on Amplifa

2011Founded

11–50Employees

Basel, SwitzerlandHeadquarters

About Agrexis AG

Agrexis AG is an independent, scientific and regulatory consultancy headquartered in Basel (Switzerland) with a presence in Singapore. The company supports manufacturers of plant protection products, bioprotectants, biostimulants and fertilizers across the entire registration lifecycle – from data gap analysis and study design and study monitoring to dossier preparation, submission and authority correspondence. The consulting services are provided under Regulation (EC) No 1107/2009, Regulation (EU) No 528/2012 and Regulation (EU) 2019/1009 as well as comparable frameworks outside the EU, including in Europe, Asia-Pacific, Africa, the Middle East and Latin America via a network of local partners. The team consists of senior experts in Regulatory Affairs and product safety with industry and consulting experience. As Agrexis holds no own product portfolio, its consulting is free of commercial conflicts of interest. In addition, the company offers project management, IUCLID dossier services (including CADDY), training, regulatory due diligence as well as AI-supported research data management solutions such as the IUCLID Integration Platform.

Site: CH-4002 Basel
Processes: Regulatory Strategy, Regulatory Science & Product Safety, Study Design and Study Monitoring, Project Management, Dossier Preparation (among others IUCLID, CADDY), Artificial Intelligence & Research Data Management, IUCLID Integration Platform, Training
Materials: Regulation (EC) No 1107/2009, Regulation (EU) No 528/2012, Regulation (EU) 2019/1009, IUCLID & CADDY, AI & Research Data Management
Founded: 2011
Employees: 11–50
Industries: Agrochemicals, Plant Protection Products, Bioprotectants/Biopesticides, Biostimulants, Fertilizers, Biorational Industry

01
Regulatory Strategy
02
Data Gap Analysis & Study Design
03
Study Monitoring
04
Dossier Preparation (IUCLID/CADDY)
05
Submission & Authority Correspondence
06
Task Force Management

Services & Methods

REG-1107/2009

Regulation (EC) No 1107/2009

Registration of plant protection products and biopesticides in the EU including AIR renewals and zonal product authorisations.

REG-528/2012

Regulation (EU) No 528/2012

Framework for biocides, among others bioprotectants with biological mode of action.

REG-2019/1009

Regulation (EU) 2019/1009

Registration of biostimulants and EU fertilising products.

IUCLID

IUCLID & CADDY

Dossier preparation and maintenance including IUCLID Integration Platform and parallel CADDY dossiers.

AI-Data

AI & Research Data Management

Automation of dossier and literature tasks in traceable, audit-ready processes.

Locations

Basel

Headquarters

Singapore

Branch office

Industries

AgrochemicalsPlant Protection ProductsBioprotectants/BiopesticidesBiostimulantsFertilizersBiorational IndustryBiostimulants

Additional services

Regulatory StrategyRegulatory Science & Product SafetyStudy Design and Study MonitoringProject ManagementDossier Preparation (among others IUCLID, CADDY)Artificial Intelligence & Research Data ManagementIUCLID Integration PlatformTrainingTask Force ManagementRegulatory Due DiligenceData Access and CompensationRegistration under Regulation (EC) No 1107/2009, (EU) No 528/2012 and (EU) 2019/1009

History

2011
Foundation of Agrexis AG in Basel.