toxicology, GLP  and product safety consulting and training
REACH toxicology consulting
REACH is a complex European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The REACH Regulation assigns greater responsibility to industry to manage chemical risk and for industry to provide safety information on the chemicals that they manufacture or use. Manufacturers, importers and down-stream users of basically all chemicals produced at an annual rate of over 1 ton will be required to gather information and to register the chemical.
The new law entered into force in June, 2007, has provisions that will be phased-in over 11 years.  The clock is ticking on the timelines that are enforced by the European Community.  The deadline for registering chemicals manufactured in quantities over 1000 tons and for Carcinogenic, Mutagenic or Reproductive toxins (CMRs) manufactured over 1 ton was 30 November 2010.
We will investigate and provide guidance for FDA GLP, FDA Redbook, OECD and ICH regulation/guideline compliance. We effectively design protocols, initiate, monitor and report GLP and range-finding preclinical studies. If requested, we place studies with a reliable worldwide network of contract research laboratories (contract research organizations, CROs).
Robin Guy Consulting will work with your company, consortia, down-stream users, and Only Representatives to run more efficient Shared Information Exchange Forums (SIEFs). We can provide REACH Toxicology Consulting services, including:
  • Review Toxicology and Preclinical Studies for dossier support:
    • Independent assessor’s review
    • Robust study summaries
    • Chemical safety assessment
  • Data gap analysis assessment and gap-filling strategic planning
    • Design and place needed studies at qualified contract research laboratories, including GLP studies for toxicology studies
    • Monitor studies and provide Quality Assurance support
  • Conduct literature searches
  • Provide QSAR data
Services are also available for auditing and reviewing studies conducted internally or at outside laboratories (Quality Assurance Audits and Reports) by a RQAP-GLP professional (GLP certification).
Clients may also request laboratory GLP facility audits (see Good Laboratory Practice page). Due-diligence audits are also performed for nonclinical studies and programs.
Robin Guy Consulting, LLC also is available to provide a leadership role on project management teams in evaluating and interpreting the safety of existing and potential products. We summarize and present toxicology and other nonclinical data to facilitate critical decisions for the development, acquisition and commercialization of potential products.
 
   
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