Harlan Laboratories assists formulators and manufacturers to comply with the Biocidal Products Directive (98/8/EC) and national registrations under the transitional arrangements of the Directive, offering tailor-made regulatory support, including data generation and dossier preparation for biocidal products and active substances to ensure a quick route-to-market.
Harlan Laboratories’ experience under the BPD is unmatched by any other CRO with the submission of Annex I inclusion dossiers for 41 existing active substances, over 20 dedicated regulatory professionals and more than 15 years working in the pesticide field. Our services cover a variety of biocide-related issues, including product registration and authorization, testing, classification and labeling, and biocidal claims.
Harlan Laboratories’ Five-Step Compliance Program
With this program we ensure that you keep your product on the market with a smooth transition into registration or authorization under the Biocidal Products Directive 98/8/EC.
- Data gathering
- Strategy planning
-Gap analysis
-Testing strategies
-Regulatory strategy - Completion of data requirements
- Dossier preparation including risk assessment and CLP
- Dossier submission and post-submission support services
Biocide Regulatory Services
- BPD dossier preparation and submission
- Completion of R4BP
- Mutual recognition
- National registration of biocidal products
- Literature searches
- CLP classification
- Product safety assessments
- (Q)SAR and classification of products using calculation methods
- Read-across, analogue and frame-formulation strategies
- Data evaluation (reliability and acceptance)
- Data sharing and data compensation
- Project coordination
- Negotiations with authorities
- Peer reviews
- Performance of necessary studies (physical chemistry, analytical chemistry, in vivo and in vitro toxicology, environmental, and residue studies)
- Global regulatory strategies