Regulatory Submissions

Pre-market submissions define your timeline to market. EMMA International’s regulatory experts prepare comprehensive pharmaceutical, biologics, and medical device submissions. Whether combined with regulatory strategy or used as a standalone service, with EMMA International, you’re assured accurate, timely submissions that streamline your path to approval or clearance.

Pharmaceuticals

Pre-Investigational New Drug Application (Pre-IND)

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.

Investigational New Drug Application (IND)

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

Abbreviated New Drug Application/New Drug Application (ANDA/NDA)

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.

Biologics

Pre- Investigational New Drug /Pre- Investigational Device Exemption

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.

Investigational New Drug (IND) or Investigational Device Exemption (IDE)

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

Biologics License Application (BLA)

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

Medical Devices/Digital Health

Pre- Investigational Device Exemption

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.

Investigational Device Exemption (IDE)

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

Q-Submissions

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.

510(k)/ Premarket Approval (PMA)/ DeNovo/Humanitarian Device Exemption (HDE)

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

Ready to get expert assistance with your regulatory submissions? Speak with one of our experts today.

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Regulatory Submission Resources

EU MDR: Extending the Transition Period for Medical Devices

EU MDR: Extending the Transition Period for Medical Devices

The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation
The End of the COVID-19 Public Health Emergency

The End of the COVID-19 Public Health Emergency

After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.

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