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Recent Food And Drug Administration Fda Inquiries

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Fda Filing

Need an expert in regulatory filings to fda on generics. Questions are around what changes to an anda require a new filing vs. An amendment. Examples are changing dmf source or api supplier, and changing formulation for injectable drug from powder to lyo or vice versa.

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    Aloysius |President

    BREEJ Technologies Consulting Group offers Consulting Services to the Pharmaceutical Industry. As P...

    1.2 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...

    1.5 Hours Later
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    Jai |Zintro Expert

    I can help with these types of issues with ANDAs. I have developed, filed and obtained approvals on...

    1 Day Later
+11 Other Responses
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Dyslipidemia Drugs

We are looking for us regulatory experts who have experience/knowledge in dealing with dyslipidemia drugs and their approval and market launch via fda.

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    Anastasia |Consultant-Microbiologist

    My expertise is in the CMC microbiology section of NDA and BLA submissions. Most of these drugs are ...

    1.2 Days Later
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    Marc |Chief Development Officer

    Can you describe your specific interests regarding *****ledge and dyslipidemic drugs? We ...

    22.2 Days Later
+2 Other Responses
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Bioequivalence

Hi, iam dayo akinwale, the chair/president/ceo, of "ondo pharmaceutical co,inc., in palm beach, florida, united states of america. I am submitting "anda (abr. New drug application) to the u.S. Food and drug administration, for approval to manufacture generic drugs. I am in need of bioequivalence experts, companies who can write be. To approve anda application, be must be proved that the generic drug(s) is equivalent to innovator (brand drugs). I will be grateful, if you contact me through zintro. Sincerely, dayo

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    Clifford |President

    I am an expert in BE studies and ANDAs. I have conducted >50 BE studies and played a pivotal roll in...

    6 Minutes Later
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    Donald |President, Pharmaceutical Research Servi

    I have been involved in designing protocols and setting up of clinical sites to conduct bioequivalen...

    34 Minutes Later
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    Ram |CEO-Founder

    We can assist. Ram Balani...

    48 Minutes Later
+13 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 |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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3d Printed Drug

Hi zintro expert, the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for: *a brief answer to the prompt about 1-2 paragraphs including your full name *participation is voluntary no payment will be involved *if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you topic and prompt this week the us food and drug administration (fda) gave the go ahead to the first 3d-printed drug, spritam, which is designed to treat seizures brought on by epilepsy in adults and children. It was developed using zipdose, a 3d printer that creates ills by printing out thin layers of medicine in powder form, with layers of a water-based binder spread between each of the powder layers. The result is a tablet that can dissolve with a sip of water in less than five seconds. Spritam will be commercially available from early 2016 onwards. Do you think 3d-printed drugs could have the ability to transform the pharmaceuticals industry. Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name. If you have any questions, please let us know. Thank you! the zintro blog team wondering what the post would look like? Here is a sample: http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space />

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    paul |CEO management - sales - marketing - des

    I need to see the actual process before I make a comment, my initial response is the speed of produc...

    3.2 Hours Later
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    Jorge Horacio |CEO

    I think that this technology will be welcome, it is an advance over the actual systems of drug deliv...

    22.9 Hours Later
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    Scott |Vice President/Partner

    The evolvement of technology into healthcare is rapidly changing every component of medicine. It is...

    19.5 Days Later
+3 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 Drugs Manufacturing

Hi, i am looking for help on development cgmp sops for a start-up topical otc manufacturing in u.S.A

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    Klyushnichenko |VP, consultant

    I'll be glad to help you. Please see my profile. ...

    1.4 Hours Later
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    Mohamed |Quality Control Manager

    Hi, I can help you with the quality control SOPs. I have start-up experience. Kind regards, Mohame...

    1.4 Hours Later
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    James |President

    We are Pharmaceutical ***** Consultants. Experts in OTC manufacturing and testing. We h...

    1.5 Hours Later
+31 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 |Zintro Expert

    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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Drug Regulatory System

Hello , looking for expert views for drug regulatory custom projects -is dissolution required (solid oral dosage forms) of local innovator vs canadian reference product vs generic product? (how many time points, phs and number of vessels are required? Do all strengths need to go undergo dissolution testing)? -bulk stability required? -is a commercial stability commitment required? If yes, please specify. -is one dossier required per strength? -is there a policy on intellectual property in the country of submission? More specifically how is the earliest generic submission date determined? -stability data required – number of batches per strength? (zone ii or zone iv stability studies required, accelerated stability? How many batches per api supplier are needed?) -is local labeling required or special label requirement? -are there any limitations of the number of api suppliers/ finished product manufacturers/ packaging sites? -are there any limitations on the location of the sites (eg. Is a manufacturing site in india acceptable?); is local manufacturing required by law (manufacturing need to take place locally in order to obtain marketing authorization)? -is local be/ba study required (local reference product/local population)? -any specific accreditation/certification of the cro and biolab required? Many thanks in advance great regards alex

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    steve |ceo

    Great questions Alex, we answer these CMC and IP issues regularly. Contact me and we can quickly ans...

    57 Minutes Later
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    Majid |President

    Hello, I have done Bioequivalence testing for Pharma and I am very familiar with requirement. Plea...

    1.2 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...

    1.3 Hours Later
+7 Other Responses
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Fda Recall

Our law firm represents a physician in a suit in texas arising out of a drug manufacturer product recall. We are looking for an expert consultant on fda recall issues to assist us and to potentially testify at trial.

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    Jim |Founder & President

    I have experience with drug recalls and would be interested in speaking with you....

    4 Minutes Later
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    Les |Principal

    I can help you with this issue. I have more than 40 years of experience in the *****st...

    4 Minutes Later
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    Gregory |Principal

    Hello. I am former FDA-drug safety, risk *****, and drug safety board. I'd be happy to disc...

    9 Minutes Later
+20 Other Responses
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Spain Hospital Food Service

Hi, we are looking for some insights on spanish hospital food and fm services. We need to understand the client perception (as in perception of hospital authority) while selecting catering and fm suppliers for hospitals in spain. Additionally, we need to understand key score measurements of the tender processes (differentiating public, private, patient feeding, cafeteria and vending). We would be happy to compensate euro 100-125 per hour for your time. Thanks, madhulika

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    valterina |Zintro Expert

    we are specialized in hospitality (rooms, food and beverages), we can help you to ***** cater...

    4.2 Hours Later
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    Randall |Zintro Expert

    45 years of FS expertise. Dozens of trips to Spain. My wife and partner is a Spanish teacher of ove...

    4.8 Hours Later
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    Darrel |Partner

    I have previously worked in Spain on olives earlier in my career. Since then I have worked for 15 re...

    1.3 Days Later
+4 Other Responses
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Fda And Medical Devices

Hi, this is ranjan from complianceonline (training and coaching) on fda and medical devices. I would like to invite you as a speaker with our company on online webinars. Kindly let me know would you be interested as a speaker/expert and provide trainings. Thanks & regards, ranjan

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    David |Zintro Expert

    I would like to hear more about this project. ...

    15 Minutes Later
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    Mark |Clinical Associate Professor, Oregon Hea

    Hi Ranjan, Yes, I'd be interested. Please forward further information....

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

    Dear Ranjan, I would be interested. Sushma has already scheduled a "Discovery Call" meeting on 5/21...

    19 Minutes Later
+33 Other Responses
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