Interactions with Regulatory Authorities

We will address which regulatory authority might be best to seek guidance from first and at what stage in the development process would be most beneficial for a Pre-IND or Pre-CTA meeting. We will also plan subsequent interactions with the select authority and when it would be most advantageous to approach multiple regulatory jurisdictions. Our team can work with you to approach the selected regulatory authority for consultation on your product development strategy early on. This usually takes the form of a Pre-IND or Pre-CTA meeting request.