Biocides
Our Biocides team offer a wide range of support services from full Dossier preparation, submission and ongoing support to project review, product scoping & compliance. Through our close and transparent collaboration with a range of expert partners across the chemical and regulatory industry, we offer a complete service package solution. The allocation of a dedicated Project Manager – and interactive tracking boards – keeps you in touch.
National Authorisations
Our knowledge of National regulatory processes provides support and submissions to meet all local requirements and transitional measures in the UK and EU Member States.
Strategy Planning
Our wide range of experience and industry knowledge enables the efficient and clear review of those regulatory controls which apply to your products, including road mapping reports.
Product Review and Data Gap Analysis
We provide clarity for financial budgeting and commercial planning. Product pre-submission reviews and data gap identification ensure the most accurate estimations of total regulatory cost and timeframe. Our reports can include details of current & likely future requirements for your products and active substances.
Expert Judgement and Data Waivers
Our wide range of experience and industry knowledge enables the efficient and clear review of the regulatory controls which apply to your products. Using qualified outsourced partners, we ensure specialist advice is clear and cost-effective. Justified and robust data waivers often enable significant reductions in time and cost of compliance for more complex regulatory endpoints.
Compilation, submission and ongoing support of Dossiers
We can assist you through the regulatory process, from dossier preparation to post-authorisation support, providing a fully budgeted service to meet a wide range of regulatory formats and requirements.
These include the following services under the EU Biocidal Products Regulation [BPR] (528/2012):
- Preparation of IUCLID dossiers for active substances, Biocidal Product Families and single biocidal products.
- Union authorisations.
- Simplified authorisations.
- Submission of dossiers via R4BP3.
- ‘In Sequence’ and ‘In Parallel’ Mutual Recognition applications.
- Administrative applications.
- Article 95 & Technical equivalence.
- Treated Articles.
Post submission support
We understand the importance of continued support prior to Authorisation and beyond. Our services provide a clear and defined support throughout the evaluation process, to commercial launch and further.
Product Classification & Labelling
Our in-house CLP experts can prepare labels, SDS and packaging information to provide EU & International biocide regulatory compliance.
Project planning and budgeting
The foundation of our success is in managing your expectations with detailed budgeting, timetabling and defined targets. We pride ourselves in our openness, clarity and interactive regular reporting.
Liaison with regulatory authorities
Regular contact with Regulatory Authorities, understanding of their position – whilst robustly defending yours – ensures communication is handled effectively and efficiently.
Specialist Components
Efficacy
Our team is experienced in efficacy dataset preparation for a variety of product types including insecticides, repellents and multi-purpose disinfectants.
We can provide efficacy support, as a team with both practical laboratory and field study experience, offering services including:
- Data Gap Analysis to provide proposals on your required efficacy package.
- Data package/protocol design to match product and label claims.
- Study commissioning, monitoring & management with testing facilities to ensure harmonisation of multi-site/facility datasets.
- Comparative Assessments for candidates for substitution.
Risk Assessment:
- Tier 1 Environmental Risk Assessment.
- Tier 1 Human Health Risk Assessment.
- More complex regulatory endpoints can be commissioned to our expert partners for refinement.
Study commissioning and monitoring
Our services include planning, commissioning and monitoring of studies through GLP accredited facilities. Careful planning and placement are critical in meeting budgetary and regulatory objectives. We can recommend partners to provide any studies or work with your preferred testing facility. Externally contracted resources are carefully monitored for quality, value and costs.
Task Forces and Co-operation - Cost-sharing
We are experienced in proving independent management of shared projects, from simple co-sponsored studies to multi-party Task Forces. We offer bespoke administration services and can arrange all legal documentation.