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

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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