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Recent 505b2 Inquiries

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505b2 For Drugs

We require an expert to assist with 505b2 for a drug/device combination. We are repurposing an existing inhalation device coupled with a medical gas for home use. We plan to submit to the fda within 3-4 months and need help asap. We are looking for remote collaboration, thus location is of no importance. 505b2 has to be your core expertise. Referrals are also welcomed, thank you.

    +undefined Other Responses
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    Fda 510k

    A company that makes personal lubricant class ii medical device is looking for consultants with personal lubricant 510k submission experience

    1. Profile Picture

      John |Owner and Sr. Consultant

      My ***** filed numerous personal lubricant 510(k)s. We would be pleased to do this work on ...

      1.5 Hours Later
    2. Profile Picture

      Anne |Zintro Expert

      I have worked on many 510(k)s for medical devices (class II). I am a medical writer based in Chicago...

      2.2 Hours Later
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      Diane |Zintro Expert

      As a former FDA reviewer and 15+ years of experience in the medical device industry preparing 510Ks ...

      9.1 Hours Later
    +10 Other Responses
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    Fda 510k For Light Therapy Device

    We need to determine whether or not a led light therapy device needs a 510k. We have seen some led light therapy devices have a 510k and some do do not. Looking for someone with expertise in this specific area.

      +undefined Other Responses
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      Fda 510k

      Canadian company personal lubricant class ii medical device prepare 510k submission

      1. Profile Picture

        James |CEO

        To Whom it May Concern, my company is one of the premier leaders in the ***** 510k submissi...

        8 Minutes Later
      2. Profile Picture

        Larry |Served as CEO, VP Sales and Marketing, R

        Dear sir, I am responding to your posting on Zintro for an FDA 510(k) expert consultant. This is ...

        10.2 Hours Later
      3. Profile Picture

        Georganne |Consultant

        Hi, I have been a *****essional for over 35 years, specializing in medical devices. As a c...

        12.5 Hours Later
      +8 Other Responses
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      Fda 510k

      I need someone to write a fda 510k for a class ii product.

      1. Profile Picture

        James |CEO

        To Whom it may Concern, I have 15+ years working with Class II medical devices. I have worked with ...

        4.3 Hours Later
      2. Profile Picture

        Andrea |Principal Consultant

        Good Afternoon, I have about 20 years of experience in medical device *****irs, I can wri...

        4.7 Hours Later
      3. Profile Picture

        Paul |CEO and Co-Founder

        Please contact our in-house *****irs expert, Rich Anderson at (916) *****....

        4.8 Hours Later
      +24 Other Responses
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      Fda 510k Filing

      I need an independent consultant to file substantial equivalence 510 k with fda

      1. Profile Picture

        Polina |Zintro Expert

        I support 510K fillings for drug products. Email me at ***** ...

        1.6 Hours Later
      2. Profile Picture

        Ee Bin |Owner & Consultant

        Hi there, is it a device or drug or *****ce or IVD? cheers, Ee Bin www.access2hc.com...

        2.6 Hours Later
      3. Profile Picture

        Parul |Regulatory Consultant, Elexes Inc.

        I would love to help you on this. I have done a number of 510(k) fillings and successfully gotten FD...

        5.3 Hours Later
      +29 Other Responses
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      Medical Device 510k

      We are a contract manufacturing company. We have a medical device manufacturing license from the state of california. We manufacture private label personal lubricants that now require 510k approval by the fda. Our customer that we manufacture the lubricants for has gotten 510k approval on his product, but that is only for his brand. As a contract manufacturer we must get 510k approval on our formula and list what brands we produce it under. I need a consultant that has 510k experiences.

      1. Profile Picture

        Parul |Regulatory Consultant, Elexes Inc.

        I have done successful 510k submissions, and would love to do this job for you! Why am I a good fi...

        22 Minutes Later
      2. Profile Picture

        steve |ceo

        HI, Happy to get your *****red through the 510k process. I and my small team have gotten ...

        25 Minutes Later
      3. Profile Picture

        Timothy |Principal

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

        33 Minutes Later
      +35 Other Responses
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      Fda Compliance

      Need a special 510k filed with all the proper tests for our implantable medical device? Immediate need!

      1. Profile Picture

        New |

        Hello, I was a study director for long-term implantable products and handled ***** (in-v...

        2.6 Hours Later
      2. Profile Picture

        Prabodh |Sr Manager R&D

        I have over 25 years experience in medical devices. I have experience in the areas of FDA and CE reg...

        2.8 Hours Later
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        James |CEO

        To Whom it May Concern, I have over 15 years of 510(k) experience. I am a former reviewer for the ...

        2.8 Hours Later
      +21 Other Responses
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      Fda 510k

      We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.

      1. Profile Picture

        Ana Maria Saaibi |Director of Regulatory Affairs

        Hi, We are a consulting company with more than 7 years of experience in *****irs for medic...

        2.8 Hours Later
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        Cynthia |Regulatory Affairs Consultant

        Hello, I am an independent consultant specializing in class II 510(k) submissions. Please contact m...

        6.3 Hours Later
      3. Profile Picture

        Courtland |CEO

        Please let us know how we can assist you. Our firm is celebrating 11 years. Our average age in i...

        6.6 Hours Later
      +14 Other Responses
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      Fda 510k

      We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.

        +undefined Other Responses
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        Fda Pre-submission

        Hi! we need a pre-submission to define the regulatory strategy for an innovative yet simple electrical non invasive medical device serving an under served population of patients. I understand that you might need more details, but i just want to check if the pricing is within our budget. Please let me know what will be your ballpark quote (or price range) and timeline for the following. If your price range is within our budget, i will contact you to move forward with the project. 1. Advising on what things will be needed for preparing a pre-submission. 2. Preparing all sections of the pre-submission. 3. Corresponding with the fda and answering all questions on the pre-submission. 4. Scheduling a meeting with the fda and discussing questions that need to be clarified to clearly define the regulatory strategy (eap/denovo/pma, etc). 5. Creating a final report for lir on regulatory path and testing needed, moving forward, based on the discussion with the fda. Also if we need a 510k. What are the typical timeline and rates for a 510k? Thanks a lot! sumi

        1. Profile Picture

          Alan |President and Senior Consultant

          Dear Sumi, I would be happy to help, and have a background both in such medical devices (including t...

          4.2 Hours Later
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          steve |ceo

          Hi Sumi, We are happy to help, having accomplished over 230 successful medical device submissions to...

          4.3 Hours Later
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          Les |Principal

          Hi Sumi, I can assist you with your project. I have more than 40 years of experience and have a su...

          4.6 Hours Later
        +15 Other Responses
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        Fda 510(k) Guidance

        I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device. My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds. Thank you.

        1. Profile Picture

          Courtland |CEO

          Please contact us about your 510k submission. We can readily help you in ***** requirement...

          9.3 Days Later
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          William |President

          I wanted to follow up on my submission. I believe that the work we have performed on surgical visual...

          22.4 Days Later
        +3 Other Responses
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