Regulatory Submissions

Don’t forget the most important step on your path to market. EMMA International helps you navigate FDA requirements and prepare your pre-IND package, thus ensuring you gain valuable feedback from the FDA.

EMMA International takes care of the heavy lifting to prepare a comprehensive IND package so you can start your clinical investigation.

Our regulatory experts compile your abbreviated new drug application or new drug application to ensure your drug product reaches all the commercialization milestones on your timeline.

Don’t forget the most important step on your path to market. EMMA International helps you navigate FDA requirements and prepare your pre-IND package, thus ensuring you gain valuable feedback from the FDA.

EMMA International prepares your investigational submission package to assure your readiness for clinical investigation.

Our regulatory experts work alongside your stakeholders to compile your BLA. Our track record of successful approvals speaks for itself.

Don’t forget the most important step on your path to market. EMMA International helps you navigate FDA requirements and prepare your pre-IDE package, as applicable, thus ensuring you gain valuable feedback from the FDA.

EMMA International can prepare your investigational submission package to ensure your readiness for clinical investigation.

Getting innovative products to market can be a daunting task. With EMMA International on your side, a Q-Sub becomes an even more valuable mechanism to obtain some feedback from the FDA. We compile the documentation, facilitate pre-submissions and meetings with the FDA, and address all concerns raised by the agency on your behalf.

From former FDA officials to former regulatory affairs executives, our regulatory experts guarantee the outcome of your regulatory submissions regardless of complexity.