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Recent Fda Approval Inquiries

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Ce And Fda Approval

New medical device company seeking regulatory medical device expert for ce and fda approval process. Prefer regulatory experience with extracorporeal devices including dialysis and apheresis filter technologies.

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    Mercedes |Principal Consultant

    I have over 30 years of experience in medical devices, a good portion of that with hemodialysis mach...

    12.8 Hours Later
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    Denise |

    Happy to help you out. Expert in CE mark and FDA submissions and approvals. Specialize in medical de...

    12.8 Hours Later
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    Denise |Zintro Expert

    Our company specializes in medtech *****tegy in the US and Europe. Excellent track record ...

    12.9 Hours Later
+35 Other Responses
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Skin Mask Fda Approval

I am importing a product from overseas into the u.S. It is a skin mask made from volcanic clay (kaolin) and water (sole ingredients). I am doing due diligence to determine 1) whether this product requires fda approval or any lab tests done; and 2) labeling requirements. Thank you.

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    DENNIS |Partner

    the product will require a Challenge Test (Microbiological Determination). For labelling requirement...

    37 Minutes Later
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    Jonathan |Principal

    Microbial (Total and Objectionable) a well as "label" claims....

    37 Minutes Later
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    Evelyn |Owner & Principal Consultant

    Based on the ingredients and your brief description, the product would likely be classified as a cos...

    41 Minutes Later
+11 Other Responses
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Fda Compliance

Dear sir i am a quality assurance manager of one of the biggest pharmaceutical company in turkey. I am looking for a fda compliance consulting company to assist us for fda approval process.

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    Cynthia |Executive Vice-President

    Please allow this note to introduce my company, American Technical Consultants to you. I am sure we...

    5 Minutes Later
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    Anastasia |Consultant-Microbiologist

    Is this for a sterile drug, solid dosage form, generic or brand name, biotech or small molecule? I c...

    9 Minutes Later
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    Maha |Senior Consultant

    Dear Sir, I believe I can help you. I am a consultant with extensive experience with the FDA approva...

    1.5 Hours Later
+19 Other Responses
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Fda Approval For Medical Device

Mechanical facial stimulation on the skins surface.Natural. Targeted cellular response and lifting effect. Non invasive non agressive.

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    Byron |President/Consultant

    I am.confident that either myself or someone else from our company can help you. Your first step wil...

    13 Minutes Later
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    Diane |Sr RA/QA Consultant

    Have many years experience with FDA submissions, including medical device. Former reviewer with exp...

    21 Minutes Later
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    Rita |Principle

    Dear FDA-7YtQ3F, I would be more than happy to help you with this project. I would need some addit...

    5.9 Hours Later
+4 Other Responses
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Fda Approval

Hi, i want a product tested for fda approval

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    David |Zintro Expert

    Can you please ***** the project?...

    48 Minutes Later
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    Alan |President and Senior Consultant

    I will be happy to use on your behalf my experience and expertise in having products tested to meet ...

    48 Minutes Later
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    steve |ceo

    Hi , Happy to help. Please contact me so we can discuss what testing needs to be done for the approv...

    50 Minutes Later
+18 Other Responses
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Fda Approval

I have a product which is a gel that treats wounds, burns, and type 2 diabetic cracked skin. This has a ec mark in europe and is a 2b medical device. I have all of the microbiology reports and would like to know how to proceed towards fda approval. The product is completely natural and is comprised of oxygen and seawater. I also saw there was a no classification option under fda under wound kit without drugs. This would be excellent for both otc as well as hospitals. Can someone please tell me how to proceed.

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    Les |Principal

    I can help you with this project. Wound care products are considered (usually) medical devices in t...

    7 Minutes Later
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    Timothy |Principal

    I am a former FDA Review Chemist who served in the Office of Generic Drugs specifically in the revie...

    16 Minutes Later
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    Jack |President

    I have experience in Drugs, OTC, Medical Devices and Cosmetics. One would need to know more about t...

    1 Hour Later
+13 Other Responses
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Otc Product Approval Us

We are launching a new iron supplement in the us and require someone to provide regulatory affairs advice on the fda approval pathway for the product. 

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    Parul |Regulatory Consultant, Elexes Inc.

    Thank you for the inquiry! I would love to help you on this! I run a small *****ice firm...

    12.5 Hours Later
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    Rajib |Zintro Expert

    Hi ,This is Rajib and i am a *****irs Pharmacist.I have five years of experience in Drug R...

    12.7 Hours Later
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    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    13.9 Hours Later
+12 Other Responses
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Medical Device Class I

My class one medical devices are being held for fda examination. Imported product from taiwan supplier without a fda registration. Our company is registered. These products are custom made from our specifications and packaged here in seattle. The tariff classification is accessories for wheelchairs. Any idea why we would be under a fda exam or how we can get our products released?

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    Kevin |Principal Consultant

    ComplianceAcuity can help, but we will need more *****ils. Let's talk....

    38 Minutes Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Inquirer, I have had a lot of experience in this area. What I can tell you is that FDA regardi...

    2.3 Hours Later
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    John |Owner and Sr. Consultant

    You possibly are under FDA exam because the exporting company does not have an establishment registr...

    2.5 Hours Later
+10 Other Responses
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Disposable Medical Supplies Fda Approval

Hello. We are a new company looking to bring disposable medical supplies from china to the usa. We are focusing on a small number of products initially. The manufactures we are looking to work with are based in china and have fda certification themselves but from what i have learnt we also have to apply for fda approval, we will be re-branding the products and importing. We are unsure as to what we need to do to ensure our products are compliant and what paper work/fees are required and would be grateful for any advice/guidance you may have. Kind regards dr chauhan

    +undefined Other Responses
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    Fda Compliance

    I am looking for speaker/consultants form fda compliance industry who are ex fda's . Please drop me a message if this is suitable & this is for engagement in 2015 .

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      Timothy |Principal

      I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

      5.2 Days Later
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      Mithilesh |Advisor

      I am not from FDA. However, have more than 30 years experience in Pharma Sector & presently working...

      5.7 Days Later
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      Balvant P |PRESIDENT

      I have a proven expertise / experience in the overall areas of Quality (QA/QC) / FDA's GxP Complian...

      5.8 Days Later
    +5 Other Responses
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    Medical Device Fda Approval

    Looking to get dental xray sensor fda approved

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      DANIEL |CEO

      Hello. We would be happy to help you. within our consulting group we have an FDA and QMS expert. Ple...

      1.4 Days Later
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      Cartik |Imaging Principal

      I have experience with fda approval and orthodontic devices. I could help you obtain the FDA approva...

      1.6 Days Later
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      Kevin |President

      I have a great deal of experience in digital imaging technology for medical *****. I would be...

      8.3 Days Later
    +10 Other Responses
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    Nephrology

    Nephrologists for expert panel a well-known biopharmaceutical company just came out with a new drug to treat abnormal lab values that can trigger adverse events in the kidneys. Although the new drug was approved by the fda, it received a black-box warning (the strictest warning put in labeling). On behalf of our client, we are conducting a research study to understand how the black-box warning may affect the adoption of the new drug. We are pooling together a group of nephrologists into a 4-day online engagement to assess how the black-box warning may be perceived. Seeking expert participants: nephrologists and kidney specialists, who diagnose and treat kidney diseases  expectations: log in and participate at least once a day at your convenience to answer the daily question posted by the facilitator - over a 4-day period. (this may include open ended questions or simple surveys and responding to peers) ~ roughly 20 - 40 minutes per day timing: february 8 - 12 value: earn $500 for the engagement learn about trends in your space and content that can help you improve your own work connect with peers and expand your network enhance your reputation as a leading thinker on topics of passion and expertise screening question: given the focus for this engagement, why do you think you’re uniquely positioned to provide valuable feedback to this client? Please be specific with regards to your background, perspective, and experience.

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      Pavle |Teaching associate

      I am PhD in neprotoxicity, doing mostly animal studies, but have huge theoretical knowledge about ki...

      2.2 Hours Later
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      Chinedu |MD

      I'm a general nephrologist with a broad ***** bordering on all aspects of clinical nephrology...

      7.5 Hours Later
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      New |

      I am not a nephrology expert but am a medicines management expert who is familiar with the practical...

      18.6 Hours Later
    +3 Other Responses
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