Regulatory Services
Comprehensive support for new product introductions, data development and global compliance of existing products
Intertek Experts Services Switzerland provides a comprehensive regulatory resource for customers to develop and implement worldwide regulatory strategies. It is independent from laboratory testing houses and includes services related to new product introductions, data development as well as compliance of existing products with local and global regulations. The services are based on our extensive global regulatory knowledge and decades of practical experience dealing with chemicals regulation. The organization has offices located around the world and has established a strong, direct network with local as well as regional trade associations and government authorities.
Notification/registration of new chemicals
- Strategic consulting, Pre-Registration, Registration, Consortia management and SIEF/Consortia representation, legal representation in EU (‘Only Representative’), dealing with authorization (PBT, CMR).
- integrated test strategies/non-testing, identification of analogues/read across/grouping data evaluation (Klimisch criteria), collecting relevant data from public domain, chemicals safety report preparation, classification and labeling risk and exposure assessment/scenarios
Global chemicals hazard communications and management
- Hazard classification and communication
- Chemical inventories and product registers
- Control regimes (CWC, drug precursors, dual uses, import/export)
- Product safety and risk assessment
Tox and ecotox testing
- Notification requirements for chemical substances
- Registration under REACH or assessment in HPV programs
- Profiles for hazard classification of chemicals
- Protocol, data and reports to meet international regulatory standards
- Placement and monitoring of studies
Application registration worldwide
- Guidance in the key steps to achieving compliance of end-use articles for commercialization into the market.
- Indirect food contact applications
- Indirect contact with drinking/potable water (NSF Scheme)
- Registration of medical devices and biocides
- Global legislation development and training
- information and advice servicestailored to needs covering legislation around the world.
- Special training sessions, in-house or at the customer’s sites
Our main business areas are
Food & Nutrition
- Food Additive Submissions
- GRAS Determinations
- Dietary Supplement Notifications
- Novel Foods Submissions
- Health Claim Substantiation
- Non-clinical & Clinical Study Development and Monitoring
- Food Contact Notifications
- Food Application Biocides
Pharmaceutical & Healthcare
- Non-clinical study design, CRO study placement, monitoring & report review
- Regulatory affairs
- Strategic planning
- Program management
- Toxicology consulting and expert reports
- Due diligence
Specialty Chemicals & Performance Materials
- New Substance Notification, Strategic Planning, Dossier Preparation & Stewardship
- Hazcom Training & Support
- Materials Safety Data (MSDS) Preparation
- Workplace & Consumer Label Advice
- Hazard Classification, Product Safety Evaluation
- Product Chemistry Review
- Technical Support to Non-Compliance Resolution
- Supply Chain Mediation & Government Relations, EU REACH and BPD support
Agri, Biotech & Consumer (ABC) Products
- Developing regulatory strategy and submissions
- Product safety & efficacy evaluations for cosmetics/cosmeceuticals
- Substantiating waiver requests and read-across arguments
- Developing exposure limits and residue tolerances
- Conducting human health and environmental risk assessments & mechanistic evaluations of unique chemical hazards
- Third-party technical liaison