Happy New Year from EMMA International!

by | Jan 5, 2018 | Gene and Cell Therapies, Medical Devices, Pharmaceuticals

Happy New Year from EMMA International!

 

Your ‘one stop shop’ for all your quality, regulatory, and compliance needs.

 

The new year brings with it the halo of fresh starts and new opportunities.  What hasn’t changed are the usual constraints of time, budgets, and people.  Position your thinking a little different this year and set yourself up for success.

EMMA International Consulting Group, Inc. can be that resource to help you achieve new product lines in your plant, open new area of business by obtaining that ISO certification or adding an additional certification.  Do you want to be sure to shore up any areas before a supplier or FDA audit?  Let a pre-audit help discover those areas of concern and get remediation underway, or set your mind at ease that you are ready to take on that audit.  The work still needs to happen but need to save on overhead?  Let us handle your CAPA process, do your validations, handle customer complaints, conduct supplier audits or even be your Quality Department!

We can take the lead in preparing your NDA, PMA, 510(k) and other FDA submissions.  We can also respond to FDA, if you have received a 483 or a Warning Letter. Let us advocate for you.

EMMA International is a global leader in management consulting services, with headquarters in Farmington Hills, MI, as well as offices in FL & PA. We focus on the Biotechnology, Pharmaceuticals, and Medical Device industries.

Backed by extensive knowledge and industry experience, EMMA International consultants are innovative and focused on addressing your needs. We do not merely render advice, outsource our talent, or provide “cookie cutter” solutions, as many consulting firms tend to practice. We do not “leave you hanging” with a process or system that is foreign to your organization and ultimately becomes unworkable. Our mission is to provide significant value to your operations and leave you completely satisfied that your expectations were fulfilled. We work within your corporate culture and alongside your employees to do the “heavy lifting” required to make improvements meaningful and permanent.

Start the new year off right by calling EMMA International.  Let our sales team answer all your questions and guide you to a successful 2018!  You can reach us at 248-987-4497.

Learn more about us on our website, www.emmainternational.com, and stay in contact for news, blogs, webinars and other points of information on our LinkedIn and Twitter accounts.

We wish you and your business the best in 2018 and look forward to partnering and supporting your needs this year.

All the Best,

The EMMA International Team

 

Emma International

Emma International

More 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.

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