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Recent Fda K Inquiries

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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
  2. Profile Picture

    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
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    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 Compliance

Looking for a former fda compliance expert in drugs specializing in data integrity and quality metrics. This engagement is for october 2016

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    Tye |Principal

    My consulting firm, Spillum & Associates, LLC provides leadership & support of FDA enforcement & rem...

    5.5 Hours Later
  2. Profile Picture

    Timothy |Principal

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

    5.8 Hours Later
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    Courtland |CEO

    Please let us know if we can assist you with your project. We are well established in the industry ...

    6.2 Hours Later
+8 Other Responses
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Fda Compliance

We are a small startup medical device company and are getting ready to start production of an fda class 1 device. We need a consultant to help us file the necessary documentation with the fda and iso, and to establish a small production facility in northern nj

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    Plamena |President & Principal Consultant

    Our consultancy will be happy to assist with your project. We have experience with class I devices ...

    1.7 Hours Later
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    Monther |President

    Hi. I'll be glad to assist you in the ***** being in compliance. Launching class I devic...

    1.8 Hours Later
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    Denise |Senior Consultant

    Happy to help. Our company specializes in helping small start-ups. ...

    1.9 Hours Later
+22 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

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    Steven |Owner

    I recently organized single use equipment, volumes, reactors, filter systems for a biotech project s...

    14.7 Hours Later
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    Dr Venkat |Global Consultant

    Dear Dr Chuahan, I can assist you n this and can arrange support from current as well as Ex FDA Insp...

    14.9 Hours Later
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    John E. |Principal; Member-Manager

    You will have to register w the US FDA and pay an annual fee. You will have to come under parts of t...

    15.5 Hours Later
+13 Other Responses
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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 |Senior Consultant

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

    12.9 Hours Later
+37 Other Responses
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Fda Cmc Regulatory

I am looking for a consultant with expertise regarding the qa process for fda cmc regulatory approval. Ideally, the consultant would be familiar with oral agents and elixirs.

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    Tai Wei |Sr. Director of Drug Development Technol

    I believe I should be able to help you with your query. I have been responsible for CMC in all our ...

    1 Hour Later
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    Plamena |President & Principal Consultant

    Hello - our consultancy can definitely assist you with your project; I have 10 years of RA with a fo...

    1 Hour Later
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    Nicholas |Director R&D

    I am a *****rance consultant and worked in the pharma area for over 30 years. The last te...

    1.1 Hours Later
+24 Other Responses
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Fda Regulatory

Join our medical device startup - fda regulatory expert - 505(b)2 we are a small medical device startup developing a combination injectable drug delivery device. We need an experienced fda 505(b)2 expert who can join our team to help us navigate the regulatory process. We are open to providing equity or milestone based compensation.

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    Andrea |Principal Consultant

    Hi I have helped many start-ups successfully reach their *****s. I would ***** op...

    50 Minutes Later
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    Darshan |FDA Regulatory & Compliance Attorney

    I am an FDA *****rney (and also a licensed pharmacist) who helps companies of varying size...

    52 Minutes Later
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    Larry |Served as CEO, VP Sales and Marketing, R

    My background includes 25 years as a FDA *****irs Expert consultant. I also was CEO of two...

    58 Minutes Later
+34 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 Quality Metrics

Hi, i'm a conference producer based in mumbai. I'm working on the 3rd annual data integrity, reliability and quality metrics workshop scheduled from october 18th-19th, mumbai and 20th-21st october, hyderabad. I'm working with former fda experts for this project. I was looking out for a former fda expert who could cover on quality metrics

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    Timothy |Principal

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

    2.5 Hours Later
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    Eugene |Scientific Director

    Hello. I'm EMEA Expert not FDA. can help you...

    2.9 Hours Later
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    Polina |Oversight & Monitoring Lead, Health Care

    I support FDA compliance and *****irements for Fortune 500 Pharma. Hence, I can discuss Qu...

    3.7 Hours Later
+8 Other Responses
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Fda Submissions

We are software development company invovled in medical device software development. Device in question is operated by means of "smart watch" modified for this particular purpose. We need a technical expert/consultant to prepare this smart watch +software for fda submission

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    James |Managing Director

    Experienced in Software apps for mobile devices. Please send further details. Jim Mackenzie QualiMe...

    21 Hours Later
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    Bill |Sr. Project Manager

    You are in the SOUP! software of unknown provenance. How you structure your claims, essential perfor...

    21.4 Hours Later
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    John |Founder and Managing Director

    I have extensive experience in this area, please contact me for further discussions. John Hoffman - ...

    21.4 Hours Later
+17 Other Responses
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Fda Compliance

Looking for fda compliance expert with minimum of 15 years of experience to be a consultant speaker.

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    Darshan |FDA Regulatory & Compliance Attorney

    Can you be more specific on the type of compliance expertise you are looking for?...

    2 Hours Later
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    Courtland |CEO

    I have 33 years of experience on GMP compliance. I have a group of friends (mainly ex FDA) that can...

    2.2 Hours Later
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    Sue |Team Lead - US Complaints Operations

    I have drafted responses for 483 ***** ***** and responses and presented directl...

    2.5 Hours Later
+12 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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