toxicology, GLP  and product safety consulting and training
Product Safety Assessment & Toxicology Reviews
Toxicology summary preparation is a specialty at Robin Guy Consulting, LLC. We will partner with you on your FDA Regulatory Submissions We prepare toxicology, pharmacology and pharmacokinetic components for regulatory submissions.
These regulatory submissions include:
  • Investigational New Drug (IND)
  • IND annual reports
  • New Drug Application (NDA)
  • Investigational Device Exemption (IDE)
  • 510(k) Premarket Notifications
  • Premarket Approval (PMA)
  • Clinical trial application
  • New drug submission (TPD, Health Canada)
  • Food Additive Petition (FAP)
  • Generally Regarded as Safe (GRAS) dossiers (including self-determinations)
Using our network of experts, we are able to organize a group to complete entire regulatory submissions. Please inquire about this service.
 
   
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