Regulatory Affairs Consulting

Intrinsik’s scientific experts provide regulatory strategy and support from the pre-clinical stage through to market, including content authoring, and preparation, submission and maintenance of applications for registration of small molecules, biologics, natural health products (NHPs), and cosmetics in the United States, Europe and Canada.

Lead teams in North American Authority Meetings (FDA, HC)
Regulatory consultation meetings, including pre-submission meetings
Regulatory strategy
Product assessment and classification
Expedited approval pathways (e.g., fast-track, breakthrough therapy, priority review)
Orphan drug designation
Special protocol assessments
Pediatric plans
Clinical trials (IND, CTA)
United States NDA via 505(b)(1) and 505(b)(2) pathways
Canadian NDS, DIN, NHP PLA
EU MAA
Drug Establishment Licence and Site
Licence application support
Post approval and lifecycle management
Product label development and review
Claims assessment and promotional material review
eCTD publishing
United States agent and Canadian regulatory representative