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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
  2. Profile Picture

    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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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 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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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
  3. Profile Picture

    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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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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    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 Approval

    We are looking for an expert to help with fda approval for compound cream for pain.

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      Jeffrey |President and Managing Director

      I have extensive experience withthe development of a variety of analgesic agents, ranging from opioi...

      1 Minute Later
    2. Profile Picture

      Timothy |Principal

      I am former FDA and as a consultant for 18 + years I have furnished clients with pharma development ...

      1 Minute Later
    3. Profile Picture

      Parul |Regulatory Consultant, Elexes Inc.

      Hi, I can help you by choosing the best *****ce for you, writing your submission and corres...

      16.6 Hours Later
    +6 Other Responses
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    Medical Device Fda Approval

    Looking to get dental xray sensor fda approved

    1. Profile Picture

      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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    Fda Approval

    We try to get fda approval for hirudin blood collection tube, a blood collection tube use hirudin as universal anticoagulant. Based on our knowledge, there is no such a similar product in current us medical market (we understand this may be a hurdle). We are looking for help and guide to obtain fda approval

    1. Profile Picture

      Ken |President

      I was responsible for Business Development/new product activities for the global leader in blood col...

      1.9 Hours Later
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      Ana Maria Saaibi |Director of Regulatory Affairs

      I can certianly help you. Please visit my website for contact ***** bmdkconsulting com....

      4 Hours Later
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      Jeffrey |Senior VP

      I managed a project to achieve FDA clearance for the CellSearch tube for collection of circulating t...

      4.6 Hours Later
    +11 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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    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

    Good morning, i am looking for assistance in getting a few items fda approved. I have detox patches, a reflexology machine and a foot/leg massager. I am near los angeles and will be able to bring our products there if need be. Many thanks in advance for your email! ashley

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      Diane |Zintro Expert

      As a former FDA reviewer, I have 20 + years of experience in both FDA and industry reviewing, prepar...

      1 Hour Later
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      Umberto |Previously: COO, VP & Director Regulator

      Dear Inquirer, I have a great deal of experience in developing medical devices and submitting them ...

      4.1 Hours Later
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      James |CEO, President, VP, Project Management,

      Hi Ashley I have developed over 30 medical devices on the market from concept through manufacturi...

      1 Day Later
    +5 Other Responses
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