Staphyt regulatory affairs: Registration dossier

Regulatory affairs and consultancy

Working side-by-side to define your regulatory strategy and guide you to successfully bring your products to market.

We help our clients to meet all aspects of their chemical and biological regulatory obligations, to achieve authorisation for the production, marketing and sale of their new or existing substances or products in their target countries.
We offer complete management of your registration projects, from understanding data requirements, managing data generation, producing the relevant dossiers and supporting the post submission.

Skills, experience and geographical coverage are three essential assets to enable our clients to achieve their regulatory affairs objectives.

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Strategic and regulatory consultancy

Our senior consultants offer support and advice to find the best and most efficient route through the regulatory landscape to achieve your objectives for product registrations & active substance approval or renewal.

Advising which countries to seek authorisation in first
Identifying the most cost efficient routes to authorisation of your product
Confirming which studies to start first, so that decisions can be made early
Outlining the timescale and key decision points

Data gap assessments and audit

We understand the data requirements set in each regulatory regime and country and can advise you on which data needs to be generated and provide an indication of the cost and timelines needed.

For active substances – new and renewals
For products – new product applications, renewal, data matching

Studies management and monitoring

If new studies are needed, we can liaise directly with Staphyt’s CRO departments and/or other CROs to obtain quotes and make recommendations on which ones have the best experience to undertake the work. We will act on your behalf to confirm the study design, to monitor delivery and to resolve queries. We will also review preliminary results, draft reports and finalize reports ready for inclusion in the dossier.

Reviewing and agreeing study protocols
Arranging for test materials to be provided
Reviewing interim & final reports
Managing import permits for experimental products (RET/EUP) and registration hold

Risk assessment

Preliminary risk assessment

If there are any concerns about registrability, we can take data from key areas of the dossier and undertake an initial risk assessment before proceeding to a full risk assessment, dossier preparation and submission.

Reviewing key toxicological, environmental fate and ecotoxicology data to identify any problems ahead of time.
Requires early investment, but reduces the time needed for the dossier preparation.
Can inform, ‘go’ or ‘no go’ decisions, before further costs are incurred.

Full risk assessment

When all data is available we will conduct a full risk assessment to ascertain whether the proposed uses can be supported and authorized in the countries where authorisation is being sought. The risk assessment uses approved methods and models and takes account of the way the product is used and the main routes of exposure to the environment (non-target species, consumers, users)

Agronomic practices (PPP)
Climatic conditions (PPP)
Soil types (PPP)
Differences in indicator species
Variation in typical diets for consumers

Higher tier refinement

Our experts have considerable experience in identifying solutions when problems are identified in the risk assessment. This may involve slight changes in the use of the product , to reduce the risk of unacceptable exposures. They will work closely with you and our wider team to find a feasible approach which may be acceptable to the regulators, whilst still maximizing your target uses and countries in which you want to market your product.

Literature search & review

Peer reviewed open literature is not just a route to identifying adverse data, but can often be used to support a dossier, for example by providing supporting scientific evidence to strengthen any justification that data is not needed.

We offer two types of service involving literature search and subsequent review of papers:

EFSA Compliant – needed for active substances under the Plant Protection Products Regulation – Art 8 (5) of Reg. (EC) No. 1107/2009
Non EFSA Compliant – useful for other applications in other regulatory sectors, to identify data or information to support the dossier.

Dossier preparation (products & active substances)

We can support you in all aspects of dossier preparation, including provision of studies, summarisation of studies for inclusion in the dossier, undertaking the relevant risk assessment and drawing conclusions for review by the regulatory authorities. We prepare all sections of the dossier and any accompanying documents that are needed.

Support with any national specific requirements

Our team has a comprehensive understanding of any specific requirements in certain countries and will guide you through what is needed. We can prepare relevant National Addenda or dossiers. We can also prepare any administrative documents in local languages where needed. Where necessary, we may be supported by our wider network of experienced and trusted third parties.

Task Force or Consortia support

From representing you as a member, to acting as Chairperson to coordinate discussions on behalf of all members, our senior regulatory consultants can play a key role in contributing to the strategic discussions on supporting key compounds for Plant Protection, Biocides or REACH.

Post submission support throughout the process

Following the submission of your application and dossier to the relevant regulatory authorities, there are several stages where you may also require our support.

Responding to questions resulting from the completeness check
Dealing with queries during the evaluation
Responding to questions during the formal commenting process/stage
Redacting of the dossier (removal of commercially sensitive information) before publication

Representation services

With a wide geographical presence, we can represent you in various situations, therefore increasing access to various markets for sales. For example, by fulfilling your need for:

Only Representative (EU and UK REACH)
Nominated Agent and Registration Holder
Appointed Representative (certain EU Member States)

Due diligence

If you are considering an acquisition, or buying the rights to certain pesticide active substances or products, you may require some advice on the implications from a regulatory perspective. We can support and advise you on your obligations and the risks involved in terms of the regulatory process, allowing you to take a more informed decision.

Regulatory Watch

If you struggle to maintain an up to date picture on regulatory developments, our Regulatory Watch service may help. This is targeted surveillance of developments with certain active substances, relevant legislation and guidance documents.

Client obligations under the EU Transparency Regulation

Regulation (EU) No. 1381/2019 came into force on 27 March 2021 and was intending to increase the transparency and sustainability of the EU risk assessment in the food chain. This places certain obligations on applicants seeking authorisations in the plant protection sector which are reviewed by the European Food Safety Agency (EFSA). This is currently limited mainly to active substance approvals, but this could potentially be extended. We can help with:

Initial registration with EFSA
Requesting Pre Submission Advice from EFSA
Notifications of intended studies & their design (for EU active substance reviews)
Notifications of studies (other EFSA mediated applications)
Redacting of studies (removal of commercially sensitive information) before publication

Regions of registration

Explore our other services

The combination of our expertise allows us to support our clients from start to finish to secure their product development.

Field services

Quality driven, we provide customised services for your agricultural research.

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Laboratory services

Test, screen and evaluate efficiently thanks to our deep expertise and state-of-the-art equipment.