Expert Guidance for Your Product Registrations
At Agrolab, our dedicated Regulatory Department specializes in providing comprehensive consulting services tailored to your needs. With deep expertise in the EU North Zone market, our regulatory experts are here to help you navigate the complexities of product registration and compliance
Whether you need ongoing support, temporary assistance, or help on an hourly basis, our team of regulatory experts is ready to assist.
Expert Guidance for Your Product Registrations
With deep expertise in the EU North Zone market, our regulatory experts are here to help you navigate the complexities of product registration and compliance.
At Agrolab, our dedicated Regulatory Department specializes in providing comprehensive consulting services tailored to your needs.
Whether you need ongoing support, temporary assistance, or help on an hourly basis, our team of regulatory experts is ready to assist.
our core services
Regulatory consulting
our core services
Regulatory consulting
Product registration pathway
Navigating the regulatory landscape for product approval across multiple EU member states requires a strategic, step-by-step approach. Here’s how Agrolab can streamline the process and ensure your product reaches the market efficiently.
1. Data Gap Analysis
Identify and Assess Requirements
We evaluate your existing documentation to identify gaps and ensure compliance with North Zone regulations. This includes assessing both necessary studies— such as residue trials, bee studies, and storage stability tests—and your overall adherence to regional standards.
3. Endpoint Refinement
Optimize Study Results
If necessary, we refine endpoints (e.g conducting GLP field trials/argumentation), adjust dose rates or add mitigations to achieve the most optimal product label.
5. Pre-submission meeting
Engage with Authorities Early
Before submission, we arrange a pre-submission meeting with regulatory authorities to discuss potential issues. This proactive step allows us to clarify endpoints, methodologies, and calculations, reducing the risk of rework.
7. Administrative Tasks
Handle Essential Documentation
Our team takes care of all administrative work, including label preparation or translations, cover letters, application forms, completeness checks, and document compilation.
9. Feedback from Authorities
Manage Follow-Ups Efficiently
Post-submission, we handle all communication with authorities, addressing follow-ups and any additional requirements to keep your application on track.
11. Post-Approval Services
Expand and Optimize Your Market Presence
After approval, we help you extend and enhance your registration through label extensions (LEX), administrative prolongations, mutual recognitions (Article 40), additional brand names, and more, boosting your market share and competitive edge.
2. Preliminary Risk Assesment
Pinpoint Critical Issues
Our experts conduct a comprehensive risk assessment, identifying bottlenecks and the most critical uses. This step helps in defining the gaps that need to be addressed for successful registration.
4. Conduct GEP and GLP Field Trials
Meet Local Requirements
Conducting field trials in line with GEP and GLP standards is crucial for meeting local regulations. While these trials can be performed by any accredited provider, our GEP and GLP departments are ready to assist, ensuring high-quality results that support your product's registration.
6. Dossier Preparation
Tailor Documentation to North Zone Standards
We meticulously prepare or update all sections of your dossier, ensuring it aligns with the specific requirements of the EU North Zone.
8. Submission to Authorities
Ensure Compliance with Local Protocols
We manage the submission process, compiling and submitting applications through the appropriate channels, such as VATIS for Lithuanian applications.
10. Product Approval
Secure Final Approval
Once your product is approved, we ensure that national labels are fully compliant with the approval letter from the authorities.
Product registration timeline
Navigating the regulatory landscape for product approval across multiple EU member states requires a strategic, step-by-step approach.
Here’s how Agrolab can streamline the process and ensure your product reaches the market efficiently.
1. Data Gap Analysis
Identify and Assess Requirements
We evaluate your existing documentation to identify gaps and ensure compliance with North Zone regulations. This includes assessing both necessary studies— such as residue trials, bee studies, and storage stability tests—and your overall adherence to regional standards.
2. Preliminary Risk Assesment
Pinpoint Critical Issues
Our experts conduct a comprehensive risk assessment, identifying bottlenecks and the most critical uses. This step helps in defining the gaps that need to be addressed for successful registration.
3. Endpoint Refinement
Optimize Study Results
If necessary, we refine endpoints (e.g conducting GLP field trials/argumentation), adjust dose rates or add mitigations to achieve the most optimal product label.
4. Conduct GEP and GLP Field Trials
Meet Local Requirements
Conducting field trials in line with GEP and GLP standards is crucial for meeting local regulations. While these trials can be performed by any accredited provider, our GEP and GLP departments are ready to assist, ensuring high-quality results that support your product's registration.
5. Pre-submission meeting
Engage with Authorities Early
Before submission, we arrange a pre-submission meeting with regulatory authorities to discuss potential issues. This proactive step allows us to clarify endpoints, methodologies, and calculations, reducing the risk of rework.
6. Dossier Preparation
Tailor Documentation to North Zone Standards
We meticulously prepare or update all sections of your dossier, ensuring it aligns with the specific requirements of the EU North Zone.
7. Administrative Tasks
Handle Essential Documentation
Our team takes care of all administrative work, including label preparation or translations, cover letters, application forms, completeness checks, and document compilation.
8. Submission to Authorities
Ensure Compliance with Local Protocols
We manage the submission process, compiling and submitting applications through the appropriate channels, such as VATIS for Lithuanian applications.
9. Feedback from Authorities
Manage Follow-Ups Efficiently
Post-submission, we handle all communication with authorities, addressing follow-ups and any additional requirements to keep your application on track.
10. Product Approval
Secure Final Approval
Once your product is approved, we ensure that national labels are fully compliant with the approval letter from the authorities.
11. Post-Approval Services
Expand and Optimize Your Market Presence
After approval, we help you extend and enhance your registration through label extensions (LEX), administrative prolongations, mutual recognitions (Article 40), additional brand names, and more, boosting your market share and competitive edge.
Facing an Unexpected Staffing Crisis?
When unexpected challenges arise—whether it's a sudden resignation, a medical leave, or maternity leave—regulatory obligations can quickly become overwhelming. That's where Agrolab's Plug 'n' Play Solution steps in to ensure nothing falls through the cracks.
Our team of experienced regulatory experts is ready to integrate seamlessly into your operations with minimal onboarding. Whether you need full-time or part-time support, we provide immediate, reliable assistance to manage your portfolio for as little as one month or as long as needed.
With Agrolab on your side, you can rest assured that all registrations and compliance tasks are handled efficiently, ensuring your business continues to run smoothly without interruption.
Our Plug 'n'Play solution has you covered
Facing an Unexpected Staffing Crisis?
When unexpected challenges arise—whether it's a sudden resignation, a medical leave, or maternity leave—regulatory obligations can quickly become overwhelming. That's where Agrolab's Plug'n'Play Solution steps in to ensure nothing falls through the cracks.
Our team of experienced regulatory experts is ready to integrate seamlessly into your operations with minimal onboarding.
Whether you need full-time or part-time support, we provide immediate, reliable assistance to manage your portfolio for as little as one month or as long as needed.
With Agrolab on your side, you can rest assured that all registrations and compliance tasks are handled efficiently, ensuring your business continues to run smoothly without interruption.
Our Plug'n'Play solution has you covered
Our core services
Advising
At Agrolab, advising is at the core of our services. We guide clients through the complex landscape of regulatory compliance, no matter where they are in their product lifecycle. Whether you're just starting product development or nearing the final stages of registration, our experts provide tailored support.
We specialize in the EU North Zone's unique requirements, helping you navigate every step of the registration process, from market viability to dossier preparation to compliance with local regulations. Additionally, our Plug 'n' Play solution offers immediate support for urgent needs, ensuring seamless integration into your team and uninterrupted progress on your projects.
Our core services
Portfolio managing
Managing a large portfolio of products can be time-consuming and complex. Our external portfolio management service takes this burden off your shoulders, handling label maintenance, approvals, classification updates, and administrative tasks. We work closely with regulatory authorities to ensure your portfolio is always up to date.
Our core services
Post-registration
After securing a registration in the EU North Zone, we can assist in enhancing your label through label extensions and mutual recognitions, widening your market reach.
Additionally, we manage administrative applications, such as prolongations, additional brand names, and manufacturing site changes, ensuring your registration remains current and compliant.
Our core services
Translations
Product labels are required to be in the local language. We can prepare and translate all types of labels (PPP, fertilizers) for all 7 North Zone countries. We have native speakers for most of the languages, and close collaboration with translators in the Agrochemical industry for the remaining languages. We can also translate marketing material, Safety data sheets and others.
Our core services
Dossier Preparation
The EU North Zone has stringent requirements, including specific models, mandatory studies, and specialized guidelines. We are experts in these criteria and provide comprehensive support across all sections of your dossier, from Part A to Part C, ensuring compliance and facilitating a smoother registration process.
Our core services
Pre-evaluation
Starting a project in the EU North Zone requires a deep understanding of each member state’s requirements and dose rates. Our Pre-Evaluation service offers a thorough Data Gap Analysis to identify any missing mandatory studies and a Preliminary Risk Assessment to determine viable dose rates.
This process provides a clear indication of the business potential in the Nordics and highlights necessary mitigations or dose adjustments. Additionally, it allows for efficient planning of GEP trials based on compliant GAP, saving you time and money by avoiding unnecessary field trials.
Our core services
Pre-evaluation
Starting a project in the EU North Zone requires a deep understanding of each member state’s requirements and dose rates. Our Pre-Evaluation service offers a thorough Data Gap Analysis to identify any missing mandatory studies and a Preliminary Risk Assessment to determine viable dose rates.
This process provides a clear indication of the business potential in the Nordics and highlights necessary mitigations or dose adjustments. Additionally, it allows for efficient planning of GEP trials based on compliant GAP, saving you time and money by avoiding unnecessary field trials.
Our core services
Dossier Preparation
The EU North Zone has stringent requirements, including specific models, mandatory studies, and specialized guidelines. We are experts in these criteria and provide comprehensive support across all sections of your dossier, from Part A to Part C, ensuring compliance and facilitating a smoother registration process.
Our core services
Translations
Product labels are required to be in the local language. We can prepare and translate all types of labels (PPP, fertilizers) for all 7 North Zone countries. We have native speakers for most of the languages, and close collaboration with translators in the Agrochemical industry for the remaining languages. We can also translate marketing material, Safety data sheets and others.
Our core services
Post-registration
After securing registration in the EU North Zone, we can assist in enhancing your label through label extensions and mutual recognition, widening your market reach.
Additionally, we manage administrative applications, such as prolongations, additional brand names, and manufacturing site changes, ensuring your registration remains current and compliant.
Our core services
Portfolio managing
Managing a large portfolio of products can be time-consuming and complex. Our external portfolio management service takes this burden off your shoulders, handling label maintenance, approvals, classification updates, and administrative tasks. We work closely with regulatory authorities to ensure your portfolio is always up to date.
Our core services
Advising
At Agrolab, advising is at the core of our services. We guide clients through the complex landscape of regulatory compliance, no matter where they are in their product lifecycle. Whether you're just starting product development or nearing the final stages of registration, our experts provide tailored support.
We specialize in the EU North Zone's unique requirements, helping you navigate every step of the registration process, from market viability to dossier preparation to compliance with local regulations. Additionally, our Plug 'n' Play solution offers immediate support for urgent needs, ensuring seamless integration into your team and uninterrupted progress on your projects.
Frequently asked questions
What products do you specialize in for regulatory consulting?
At Agrolab, we specialize in providing regulatory consulting services for plant protection products and biostimulants/fertilizers. Our expertise extends to the EU North Zone, where we have extensive experience navigating specific regulatory requirements and challenges. Regardless of product type, our team of experts is equipped to help you achieve compliance and successfully register your products.
How quickly can you start working on my project?
We understand that timing is critical in regulatory affairs, which is why our Plug 'n' Play Solution is designed to offer immediate support. Depending on the urgency and complexity of your project, we can typically begin within a few days of initial contact. Our team is ready to integrate seamlessly into your operations, ensuring that your regulatory deadlines are met without delay.
What makes Agrolab’s regulatory consulting services unique?
Agrolab stands out due to our deep expertise in the EU North Zone market and our ability to provide flexible, tailored solutions. Whether you need short-term assistance to fill a temporary gap or long-term support for ongoing projects, our team of regulatory experts can be scaled to meet your specific needs. We combine industry-specific knowledge with a practical, hands-on approach, ensuring that your regulatory requirements are met efficiently and effectively.
Can you assist with the entire product registration process?
Yes, Agrolab offers comprehensive regulatory consulting services that cover the entire product registration process. From pre-evaluation and data gap analysis to dossier preparation, submission, and post-registration support, we offer to manage every step to ensure your product complies with all relevant regulations. Additionally, if your project requires field trials, our GEP and GLP departments are fully equipped to conduct these studies, providing you with a seamless, integrated service. Agrolab's expertise not only covers registration in the EU North Zone but also extends to conducting essential field trials, ensuring a smooth and efficient path to market for your products.
Does Agrolab offer hourly or project-based prices?
We offer both. Our pricing is tailored to the specific scope and complexity of the services you require. For instance, our Plug'n'Play solution will be more cost-effective compared to a single project. To receive a customized quote or discuss your specific needs, we encourage you to reach out to our Head of Regulatory Affairs, Sandra Schmidt, for a non-binding consultation.
Frequently asked questions
What products do you specialize in for regulatory consulting?
At Agrolab, we specialize in providing regulatory consulting services for plant protection products, and biostimulants/fertilizers. Our expertise extends to the EU North Zone, where we have extensive experience navigating specific regulatory requirements and challenges. Regardless of product type, our team of experts is equipped to help you achieve compliance and successfully register your products.
How quickly can you start working on my project?
We understand that timing is critical in regulatory affairs, which is why our Plug'n'Play Solution is designed to offer immediate support. Depending on the urgency and complexity of your project, we can typically begin within a few days of initial contact. Our team is ready to integrate seamlessly into your operations, ensuring that your regulatory deadlines are met without delay.
What makes Agrolab’s regulatory consulting services unique?
Agrolab stands out due to our deep expertise in the EU North Zone market and our ability to provide flexible, tailored solutions. Whether you need short-term assistance to fill a temporary gap or long-term support for ongoing projects, our team of regulatory experts can be scaled to meet your specific needs. We combine industry-specific knowledge with a practical, hands-on approach, ensuring that your regulatory requirements are met efficiently and effectively.
Can you assist with the entire product registration process?
Yes, Agrolab offers comprehensive regulatory consulting services that cover the entire product registration process. From pre-evaluation and data gap analysis to dossier preparation, submission, and post-registration support, we offer to manage every step to ensure your product complies with all relevant regulations. Additionally, if your project requires field trials, our GEP and GLP departments are fully equipped to conduct these studies, providing you with a seamless, integrated service. Agrolab's expertise not only covers registration in the EU North Zone but also extends to conducting essential field trials, ensuring a smooth and efficient path to market for your products.
Does Agrolab offer hourly or project-based prices?
We offer both. Our pricing is tailored to the specific scope and complexity of the services you require. For instance, our Plug'n'Play solution will be more cost-effective compared to a single project. To receive a customized quote or discuss your specific needs, we encourage you to reach out to our Head of Regulatory Affairs, Sandra Schmidt, for a non-binding consultation.
