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Regulatory Submission for a combination product - NDA eCTD FDA Expert Needed

min $50 USD / hour

Closed
Posted almost 7 years ago

min $50 USD / hour

We are currently in the beginning phases of and getting ready to prepare a New Drug Application (NDA) to the FDA for a combination product. At this point we are preparing the Investigational New Drug (IND) application to be submitted to the FDA to initiate the clinical trials and will be preparing a pre-submission meeting request to the FDA before moving forward. Therefore, we are looking for an additional regulatory affairs consultant with expertise in FDA drug application submissions (ICH, eCTD, IND, NDA, ANDA, 505(b)2, CDER, etc…) and meetings with the agency.
Project ID: 14476964

About the project

16 proposals
Remote project
Active 7 yrs ago

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16 freelancers are bidding on average $54 USD/hour for this job
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Being an experienced academic writer and well researcher. I am 100% confident I can do this project perfectly. I have already written PhD and Masters Level Paper for UK and US Students and I can easily work on it. I am familiar with Harvard, APA, MLA, Chicago and Oxford Reference Style I have been writing all sorts of scholastic and professional documents for many years. Please consider my bid for high quality work. Thanks..!!
$52 USD in 40 days
4.8 (424 reviews)
7.5
7.5
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To hire me directly, just copy and paste in your url "www.freelancer.com/hireme/expertzworld" ................................................................................... “Time. It’s what we writers fight for. Without it, we have no hope of bringing our written creations to life. We need time to study, time to read, time to ponder, time to dream, and of course – time to write.” I am majorly into • Economics, Management, Business, and Case Study • Matlab and Mathematica • Medicine, Biology, and Chemistry, • Psychology and Sociology • Technology, Architecture, and Engineering, • English, Law, and Linguistic • Finance, IT Management, Accounting, and Marketing • Computer Science • Legal writing and Contracts Among others... Working with a team, achieving this becomes possible. I write with passion, discernment, perception, and credibility which make me come up with the best result ever. Also, I deliver great results with a process that’s timely, collaborative and at a great value for my clients. I also have a very quick turn around.I write with passion, discernment, perception, credibility, and punctuality which make me come up with the best result ever. Also, I always give desired result with the sole aim of exceeding my clients' expectation and making them "wow". Once again, I always love to meet up with expectations. Just contact me for a chat, my price is fair, always at your willingness to pay. Thanks
$50 USD in 3 days
4.9 (143 reviews)
6.4
6.4
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Hello, Thank you for posting a project here on www.freelancer.com. I have briefly checked the description, and I can deliver as per the requirements however I need us to discuss for more clarity on the details, deadline and budget as well. Please reply via the CHAT button to activate the conversation or the green AWARD button for me to start right away. If this project is no longer available/deleted you can directly hire me via this url= https://www.freelancer.com/u/VirtualBrainInc.html Thanks and welcome.
$55 USD in 4 days
4.7 (89 reviews)
6.4
6.4
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Hi, I am a management professional and work on various aspects of new business and market performance. I deal with requirement associated with market research, fact finding, feasibility studies, and bench-marking. These all may be associated with product and technology to financials of a company and respective business mode of working/operations. In addition to above professional services, I also provide work linked with Business Proposals, Grants, Business Plan, Business Analysis, Marketing Plan and Financial Analysis. I am interested in the work and would like to know if we can discuss this further. Kind Regards, PRD Analyst
$55 USD in 18 days
4.5 (25 reviews)
5.1
5.1
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asadss32 Bangladesh recently Hi, I am a medical graduate, currently doing my PG in medicine. I love search and research on medical topics.... I may aid you in this job related to PREPARATION OF NDA TO FDA... I may work with your team to help you... Let's talk.... Regards. Dr. Asad less
$55 USD in 40 days
4.6 (13 reviews)
4.5
4.5
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I am a scientific curator. I am a bioinformatician and have working knowledge in Bioinformatics, Molecular Biology and Medicinal chemistry, with nine years of research experience in biomedical and environmental fields. I have ample experience on NCBI, Pubmed, AACR, ASCO and other scientific databases. Please send me details of your project. I am interested. Thanks
$50 USD in 40 days
5.0 (1 review)
1.8
1.8
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hi my name is andrew mikhail i can do this job for u in less time and u will get a perfect work i can send u more than 1 sample ;)
$55 USD in 40 days
4.8 (2 reviews)
0.4
0.4
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A proposal has not yet been provided
$60 USD in 40 days
0.0 (0 reviews)
0.0
0.0
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I am a regulatory affairs pharmacist experienced in eCTD writing and sunmission in SRA countries for both NDAs and generic drugs.
$55 USD in 20 days
0.0 (0 reviews)
0.0
0.0
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A proposal has not yet been provided
$55 USD in 10 days
0.0 (0 reviews)
0.0
0.0
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Currently working in one of the leading generic drug maker in India. I have expertise in the ANDA preparation, document review. I can assure you that I can work with NDA application also.
$50 USD in 20 days
0.0 (0 reviews)
0.0
0.0

About the client

Flag of UNITED STATES
Miami, United States
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Member since Apr 6, 2014

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