Regulatory Affairs
Toronto, Canada
Tel: 1-416-567-3290
A pharma bridge that connects West and East

iEXP'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 pharmaceuticals, biologics in the United States and Canada.

- Interaction with regulatory authorities on behalf of clients
- Regulatory consultation meetings, including pre-submission meetings
- Regulatory strategy
- Product assessment and classification
- Clinical trials (IND, CTA)
- United States NDA via 505(b)(1) and 505(b)(2) pathways
- Canadian NDS, and DIN
- Drug Establishment Licence and Site Licence application support
- Post approval and lifecycle management
- eCTD publishing
- United States agent and Canadian regulatory representative

Compliance Management

Tel:  (416) - 567 - 3290