Regulatory Research and Reporting Services
Streamlining compliance goals while ensuring transparency, accountability, and adherence to global standards.
Overview
The rapidly growing IDS regulatory research team comprises entirely of domain specialists with Masters and PhD degrees in Toxicology, Food Sciences, and Chemistry. Our services include:
- Support in hazard identification and usage of hazardous products through risk assessment
- Assuring marketability of client products by classification according to CLP/GHS and other regulations
- Support with identification of restrictions on a specific market
- Product label review services
- Identification of any registration or notification requirements for substances and mixtures in a specific market
- Specialist scientific research services for food compliance, toxicological assessment, and other chemical regulatory requirements – assisting in dossier preparation, data gap analysis, review and analysis of physicochemical, ecotoxicology, and toxicological data, CSA/CSR preparation, human and environmental exposure scenarios (ES) and Risk Assessment
Our Specialized Research Services
Toxicological Regulatory Research Services
Services comprise of regulatory data evaluation/reviews to analyze chemical compositions to determine hazards and risks classification along with reading text and summarizing reports of toxicology data, database research, data management, literature search and review.
Our Services:
- Acute toxicological studies – oral, dermal and inhalation toxicity, dermal, and ocular irritation, and skin sensitization
- Reproductive and chronic toxicology screening studies – Risk assessment of repro toxicants; screening to OECD standards
- Exposure Scenarios – Inhalational exposure analysis
- Genetic studies
- Ecotoxicology studies
- In-house database preparation and updation (PNEC, DNEL, vPvB, In Vitro & In Vivo strains, endocrine disruptors)
Food Compliance Regulatory Research Services
IDS food compliance specialists assist our clients in researching regulatory knowledge and requirements for their food products, beverages, food contacts, and flavors. Services include capturing of regulatory knowledge and compliance requirements from countries around the world; characterization of groupings within food additives and food flavorings, food ingredients & food contact and identifying appropriate chemical identifiers.
Our Services:
- Food product regulatory compliance services for additives, ingredients, and contaminants for over 35 countries around the world
- Harmonizing food additive regulations across the globe
- Classifying the generic groups among the captured regulatory data (e.g. vitamins, alcohols, cereals etc.)
- Proofing and restructuring existing regulatory data on the client database
Food Contact Materials Services
Regulatory Research and Supply Chain Compliance Review:
- Document of Compliance (DoC) review and capture of information on client system for FCM sourced from regions/countries all over the world
- Ensure DoC compliance for each supplier – material, food type, issue date, food regulations, ingredients, overall/specific migration limits supported by test results
- Gap Review
Chemical Regulatory Research Services
IDS specialists assist in regulatory research related to chemical groupings as applicable to cosmetics/food contact/drug regulations and capture chemical regulatory requirements as standard bases.
Our Services:
- CAS-based research and compilation of properties of various chemicals for physicochemical studies as per global standards requirements
- Researching for individual chemical compounds under specific groups of chemicals
- Providing and updating existing regulatory information for chemicals from countries around the world
Product Label Review Services
Our regulatory consultants assist clients in the introduction of their chemical products, including household chemical products and personal care products, into the specified country markets by reviewing the product label information against the information mandated on the label as per target country market regulations. Service includes detailed reports on the label information, including Gap analysis with recommendations for:
- Formulation, detailing any symbols and regulatory text/hazard text/warnings (local/international language)
- Ingredients concentration, usage, storage, volume/wt., package compliance etc.
- Our chemical product labeling services support Consumer, Industrial and cosmetics labels
Transportation Regulatory Review Services
- Applicable Regulatory Labeling Requirements for Transporting the Identified Chemical Product by Land, Sea, and Air – ADR, IMDG, IATA
- Criteria for Classification and Labeling of Dangerous Goods
- Alignment with UN/ GHS regulations
- Test requirements in applicable geography (UNECE, others)
BPR Solutions
The European Biocidal Products Regulation EU 528/2012, also known as the BPR, came into force on 1 September 2013 with the purpose of regulating all biocidal products and the active ingredients used to give such products their biocidal efficacy.
The regulation ensures that all biocides existing in the EU are risk assessed for toxicity to humans and the environment before they are permitted to be placed on the market, and also that they are sufficiently active against the harmful organisms they are designed to target. This is achieved through approval for biocidal active substances and through authorization of biocidal products.
IDS through their specialist EU partner BioGenius GmbH, provides testing and registration services for biocidal products for clients seeking BPR compliance to enter into the EU market. These include:
- Development and Validation of New Analytical Methods
- Short and Long term Stability Studies
- Physical Chemical Product Characteristics and Safety-relevant Substance Data
- Product Testing and Biocide Product Applications
- Efficacy tests of biocidal insecticides and repellents actives and products including studies for the registration of application in accordance with international standards such as WHO, EPA, and BPR
Products may include disinfectants, preservatives, wood protection, textile protection, water treatment, metal fluids, rodenticides, insecticides, repellants and anti-fouling.
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