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About REACH – Chemical

REACH – Chemical REACH is based on the idea that industry itself is best placed to ensure that the Chemicals it manufactures puts on the EU / UK market do not adversely affect human health or the environment. This requires that industry has right knowledge of their substance properties and manages the potential risks. We help to ensure you are meeting this obligations, successful registration and prevent use of substances of very high concern. REACH Aims To: Get Manufacturers and Importers to: Generate information on hazards of chemicals Assess & Manage Risks of chemicals Register the chemicals for all uses Ensure Information regarding risks posed by chemicals is available To users Regulators General public Encourage Industry to Develop Substances less dangerous to health Substances less damaging to the environment Permit EU/ UK Authorities to take faster action regarding chemical risks and hazards Enhance the competitiveness of the EU/ UK chemicals industry Promote alternative methods for the assessment of hazards of substances Ensure the free circulation of substances on the internal market of the European Union

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Pharma Services

Pharma Mr. Jaimin Patel has Master of Science in Toxicology degree from University of East London, UK, and an active member of British Toxicology Society. He is approved member in United Kingdom register of Toxicologist (UKRT) and European Registered Toxicologist (ERT). He has over 13years of pharmaceutical industry experience in Toxicology assessments. He is the only Qualified Person with MSc Toxicology in UK & EU. We offer following services for Pharmaceutical industry: Permitted daily exposure (PDE) / Acceptable Daily exposure (ADE) reports for Active substances (PDE / ADE Reports) as per EMA/CHMP/ CVMP/ SWP/169430/2012 Occupational Exposure Limit (OEL) for active substances that protects workers from potential adverse health effects during the manufacturing of pharmaceuticals. Elemental impurity risk assessment(EIRA) of Active substance or Finished product as per ICH Q3D Nitrosamine risk assessment of Active substance or Finished product as per EMA / MHRA Guidance Genotoxic impurity assessment of Active substance or Finished product as per ICHM8 Toxicological safety determination of unknown Impurityas per ICHQ Q3B Module 2:Non-clinical dossier review and approval

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Service Of Cosmetic & Toys

Cosmetic & Toys We are specialized in providing Cosmetic Product safety Report (CPSR) and Toxicology Risk assessment (TRA) for Cosmetic products to be placed for the UK, EU, USA, or Canada Market, approved by Expert Toxicologist. We offer full compliance services for cosmetic products & Toys which includes their registration, maintaining product information file, responsible person compliance for each import batch along with local address for communication with authorities. All cosmetics sold to the European Union (EU) and Great Britain (GB) marketplaces are regulated under regulation EC 1223/2009 and Cosmetic Products Enforcement Regulations 2013 (as amended) where the requirements include. A Product Information File (PIF) A cosmetic product safety report (CPSR) Good Manufacturing Process (GMP) compliance Microbial Challenge Testing Product Stability Testing Confirmation that no banned ingredients are used in the product Correct Labellingin line with the cosmetic product claim Providing Safety data sheet (PSDS) A Responsible Person(RP) with an UK / EU address for the person legally responsible for the products Registration on the Cosmetic Products Notification Portal (CPNP) for the EU & Northern Ireland Registration on the Cosmetic Product Notification Service (CPNS) for GB.

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