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.

Other regulatory submission services 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)