Regulatory Information

Springborn offers comprehensive services in regulatory affairs under terms of strictest confidentiality. We are able to assist you in all areas and at all stages during the process of getting your product to market.

Our dedicated experts are familiar with European Union procedures of registration of restricted products such as pharmaceuticals, agrochemicals and industrial chemicals (REACH).

The multilinguality and scientific proficiency of our team members enable Springborn to establish trustworthy and reliable working relations with the regulators, who regard our experts as neutral and competent partners.

Our customers appreciate our flexible team concept tailored to match the individual project's scope and requirements. These special features guarantee our clients the most efficient and fastest access to the market without futile investments and loss of valuable time.

Risk Assesments

Our regulatory affairs team's experts have long-standing experience in conducting environmental risk assessments for agrochemicals, for veterinary and human medicinal products.

We can offer our clients a wide range of environmental models for both regulatory and strategic development purposes (US and EU). Modelling is also performed for estimating operator and consumer exposure risks based on the most frequently used models. Besides, our experts carefully monitor the respective European developments on model harmonisation (FOCUS, EUROPOEM) to always ensure adequate and up-to-date application of modelling.

We are member of several expert groups, to mention a few, we are part of the OECD group for development of Statistical Methods for OECD studies, we are also member of the OECD Endocrine Disruptors group for amphibians, and member of several terrestrial ecotoxicology ring groups and guidelines expert groups.

Notification and Plant Protection

Springborn's regulatory affairs team offers full and partial compilation of dossiers - including basic reviews of available databases to be submitted in order to support an application for the inclusion in Annex I of Council Directive 91/414/EEC of an new active substance, as well as national registrations of plant protection products.

The magnitude and scope of the individual project will determine the actual number and qualification of the scientists convoked to perform the task.
We adhere to the concept of Power Groups, i.e. a flexible task force of varying size and expertise will neatly correspond to the specific particulars of the regulatory project.

For product registration specific dossiers according to Annex III requirements are compiled and submitted to EU member state authorities.

Clients can have any extent of full or partial contributions by our group including the preparation of report quality checks (Tier 1), summaries of sections (Tier 2), as well as complete risk assessments. The more exacting summary appraisals and risk assessments are established by experts (senior staff) best suited for the task.

Complete dossiers are, of course, available in electronic form (CD-ROM) organised with the CADDY Retrieval Software.

Full follow-up, i.e. monitoring the progress of submitted dossiers with the authorities, through intensive liaison with the regulators can be provided by our experienced, multilingual staff. Any further documents and information required by the regulators/authorities during their evaluation progress is generated by the Regulatory Affairs Team.

Instead of maintaining an isolated regulatory affairs group, our philosophy is to create flexible Power Groups where the experience of our study directors is used to establish summaries of studies falling into their proper area of expertise, and where the senior staff with established scientific records appraises the data by performing expert risk assessments utilising, among others, the tool of modelling.

Academically-trained staff performing mere administrational tasks will be not found in our regulatory affairs team. All permanent and temporary members are experts in their fields of specialisation and are familiar with the latest technical and regulatory developments in testing.

They have been already involved for many years in regulatory processes and dossier compilation, as well as in many and diverse risk assessments.