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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.

  1. Profile Picture

    Timothy |Principal

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

    2.6 Hours Later
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    Courtland |CEO

    We might be able to assist you. We have helped others with their submissions. I have over 30 year...

    19.3 Hours Later
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    Prashant |Principal Consultant

    I have done few projects with 505b2 let me know your interest Dr.Prashant Bodhe ...

    1.4 Days Later
+4 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.

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    Dov |Director, VP

    What is the commitment in terms of hours and travel? My availability is limited to a few hours a we...

    2 Hours Later
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    Hrishikesh |VP of R&D and Manufacturing

    I would be more than happy to be the "hands-on doer". I have been through two De Novo submissions re...

    2 Hours Later
  3. Profile Picture

    Susan |President and Founder

    I have over 20 years experience and have submitted many 510ks. The largest was 8000 pages and I am e...

    2.3 Hours Later
+32 Other Responses
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Fda 510k Filing

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

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    Polina |Oversight & Monitoring Lead, Health Care

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

    1.6 Hours Later
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    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
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    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
+31 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.

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    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
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    steve |ceo

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

    25 Minutes 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...

    33 Minutes Later
+35 Other Responses
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Fda 510k

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

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    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
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    Andrea |Principal Consultant

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

    4.7 Hours Later
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    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 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.

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    John E. |Principal; Member-Manager

    Infrared *****ces are Class II. Would depend on claims and ***** heat source and applica...

    19.2 Hours Later
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    Courtland |CEO

    Please contact me for your quick response to your questions. I have over 30 years of experience in ...

    19.4 Hours Later
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    John |Principal Consultant, Owner

    Dear Inquirer: I have over 30 years of experience in the medical device field and filed my first 51...

    19.7 Hours Later
+46 Other Responses
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Fda 510k

Looking for a seasoned 510k submission expert with significant proven experience with ivds. - need someone with experience in the gastrointestinal space, medical devices and colonoscopy.

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    Ronald |CEO & President

    I have over 40 years experience filing 510K paperwork. If you want t discuss this project, I don't c...

    1 Hour Later
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    Rui |Assay Development Director

    Hi, I was working with quality and *****rtments on Cardiac and Sepsis bio-markers FDA 510K...

    4.2 Days Later
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    Stephane |Principal

    Hi, My consulting company can help you with your *****s. I have significant experience ...

    5.1 Days Later
+7 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

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    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 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.

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    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
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    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

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

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    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
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    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 |Sr. Consultant

    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 Approval Process

I am in the process of partnering up with a design/manufacturing facility to get my device to a design freeze and subsequently through all the processes to fda approval via 510k filing. I am in need of a consultant just to guide me through the process and help me out with this collaboration to ensure i do not make any mistakes when dealing with such a company.

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    Andrea |Principal Consultant

    My hourly rate....

    45 Minutes Later
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    Fayyaz |Managing Partner

    Hi, I have signficant experience in this area and will be happy to help. You can reach me at *****...

    46 Minutes Later
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    Jim |Principal

    I'd be happy to help!...

    1.3 Hours Later
+18 Other Responses
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Fda 510k

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

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    James |CEO

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

    8 Minutes Later
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    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
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    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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