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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)
- Clinical trial application
- New drug submission (TPD, Health Canada)
- Food Additive Petition (FAP)
- Generally Regarded as Safe (GRAS) dossiers (including self-determinations)
- New Dietary Ingredients Notification (NDIN)
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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