PES provides 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 pharmaceuticals, biologics, natural health products (NHPs), dietary supplements, cosmetics, medical devices and food additives and ingredients in the United States, Europe and Canada.

Services:

• 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
• Clinical trials (IND, CTA)
• United States NDA via 505(b)(1) and 505(b)(2) pathways
• Canadian NDS, DIN, NHP PLA
• EU MAA
• Medical Device Applications
• Drug Establishment License and Site License application support
• Post approval and lifecycle management
• Product label development and review
• Claims assessment and promotional material review
• eCTD publishing
• Canadian regulatory representative