+1 647-502-7261
sam.sathiamoorthy@aspirebio.ca
Our experienced regulatory team members work closely with clients to help them navigate the complex, and ever changing regulatory landscape, for all types of submissions (INTERACT, pre-IND, pre-CTA, IND, CTA, BLA). We specialize in crafting and executing regulatory strategies that address the specific needs of each client and align with product development and corporate milestones.
Our team can assist you throughout the entire regulatory process, from early meetings with regulatory agencies, to document submission through to post-approval amendment support.
- Interface with regulatory agencies
- Meeting and briefing package preparation and review
- Prepare regulatory submissions for the FDA, Health Canada or EMA (pre-submission meeting, IND, CTA, BLA)
- Respond to regulatory information requests and support post-approval changes.