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Recent Regulatory Investigation Inquiries

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Gmo Crops Regulatory Process

Looking for a professional with experience in the regulatory approval process for gmo crops in us/canada for a new gmo crop that we would like to have approved for commercial growth.

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    Nickolas |Professor Emeritus

    Contact Dr. *****ds, Agricultural Consultant, Agrino Inc, Davis, CA, USA...

    9.2 Hours Later
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    Rizwan |Machine Operator

    i want to know of tenure of crops from 30-June-17 to 30-June-18. As per Pakistan *****ially i...

    39.2 Days Later
+2 Other Responses
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Clinical Research Regulatory Service

• study objective: to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.). • following are some of the key questions: o what are the different services offered under regulatory consulting in clinical research? O who are the key users / customers of regulatory consulting services? O what are the needs for these services of different customers o what are the factors that influence the customer’s purchase decision of consulting services / products? O who are the top players providing consulting services and what is their market share? O what are the billable rates charged on an hourly basis by the companies? O why, if at all, do the rates differ across various services? O are there different rates for different customer types? What are the reasons? O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.? o what are the key market trends, growth drivers and barriers to growth etc.? o where are the key opportunities within the regulatory consulting market? Preferred expert should meet the following criteria: o location: us o industry experience of 15+ years in the clinical research industry o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research o understanding of purchase process and pricing structure of consulting services

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    Larry |Principal Consultant

    I am a former FDA official and an expert on the ***** clinical trials. I also have experien...

    2 Hours Later
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    Juan |Sr and Scientific Director Translational

    I have more than 20 years in drug development and about 10 of them in clinical development. I have b...

    3.4 Hours Later
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    Pamela |Owner/Consultant

    I have over 30 years in Clinical Research experience, as a Director of Research and *****gement,...

    16.8 Hours Later
+12 Other Responses
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Cmc Sections Of Regulatory Filings Maa

How do i compile a cmc submission package to europe & middle east concerning to maa. What do i need to prepare & submit to the authorities. If there a variation do i need to author module 2.3 & 3. How do i author the module. What is the regulatory requirement?

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    Aditya |Founder and Principal

    I have over 24 years work experience in the US Biopharmaceutical Industry focused on *****...

    1 Day Later
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    Arvind | Founder & CEO

    You will have to prepare all 5 Modules No. 1-5 to all submissions ***** theg new marketing auth...

    2.6 Days Later
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    B |abc

    Dear Inquirer, I can help you with this project. I have over 10 years of experience in global regul...

    9.8 Days Later
+5 Other Responses
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Regulatory Affair And Intelligence Services In Crop Science

Hi, i would like to understand how is r&d regulatory affairs and intelligence services with regards to crop science. My queries are related to: 1. How is regulatory affairs intelligence market? How is the procurement made (global vs. Regional vs. Local; long term vs. Short term contract; etc.) 2. How the market differs between industries (pharma/biopharma vs. Consumer care vs. Crop science) 3. How are the data sourced and validated for regulatory intelligence report (like non-governmental organizations, social media, etc.) interested experts please respond so that i can share a detailed questionnaire. I would require the information by 10th jan 2016. Thanks in advance

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    Polina |Oversight & Monitoring Lead, Health Care

    Please get in touch with me as I have a strong background in Pharma/Biopharma vs. Consumer Care vs. ...

    7.1 Hours Later
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    Aman |President

    Hi I am interested. Regards, Aman Chaudhry...

    9.3 Hours Later
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    Shaun |Vice President

    Hi One of my team could help with the below. Please share questionnaire *****. Thanks...

    9.5 Hours Later
+44 Other Responses
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Myanmar Industrial Regulatory Affairs

I need a regulatory affairs consultant, who is experienced in registration of medical devices and cosmetics in myanmar.

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    Ee Bin |Owner & Consultant

    Hi there - This is a challenging one but we may be able to help. what is the ***** the product t...

    13.9 Hours Later
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    Yevgen |Scientific Director

    Hello. I'm Director of CRO. I can organize cosmetics and medical devices ***** Myanmar. I'...

    5.3 Days Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Inquirer, I have a great deal of experience in this area. Although I have not completed a reg...

    15.3 Days Later
+6 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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Life Science Regulatory Information Software

Hello!  we are seeking experts who can assist us on regulatory information services software for a life science industry the key purpose of the research is to identify best in class sourcing practices in terms of integrated vs standalone solutions, cloud vs on - premisetop 3 vendors to engage with by benchmarking their capability and functionalities we would like to engage via phone consult with experts knowledgeable about regulatory information services. Ideal candidates should have deep knowledge of key suppliers, services they offer and key parameters to rank suppliers. Kindly drop in a note with your cv/relevant experience in the industry, if you are interested to proceed. Best regards,

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    Polina |Oversight & Monitoring Lead, Health Care

    I have extensive experience in pharma/life sciences with specific focus on ***** and compli...

    21.7 Hours Later
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    Shaun |Vice President

    Hi One of my team can help as they have just finished a project in this area. Please share full scop...

    3.5 Days Later
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    Prabhakar |Executive Director

    Dear Sir, I have 20+ years experience in *****et for development, tech transfers of produc...

    20 Days Later
+7 Other Responses
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Regulatory Guidance

We are global market research company who provide services to fortune 500 organizations is currently looking for experts in guidance on regulatory scenario of europe and africa

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    John |Director

    Can you tell me what areas are of specific interest in Europe?...

    7.3 Hours Later
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    Yevgen |Scientific Director

    I'm worldwide *****ess Expert. 15 years experience...

    11.1 Hours Later
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    Giacomo |Senior consultant

    I have knowledge of European *****es....

    6.4 Days Later
+5 Other Responses
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Myanmar Industrial Regulatory Affairs

Hi need a regulatory consultant for pharmaceuticals and medical devices for ad hoc freelance projects. Please contact me thanks!

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    Sarita |Pharma Regulatory Consultant

    I can support you in this activity. Please provide additional details about the project. Do you want...

    9.2 Hours Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Inquirer, I have extensive experience in *****irs, quality assurance, and technical ...

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

    I have extensive experience in pharma *****irs and compliance. Email me to discuss....

    10.4 Hours Later
+20 Other Responses
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Regulatory Medical Writing

Looking for writers - medical regulatory domain

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    Islara |Community Health, Public Health and Heal

    Hello, I am a professional writer with a medical and public health background and I am available to ...

    4.9 Hours Later
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    Paul |COO

    Seasoned and skilled writer for numerous clinical/*****issions and *****ments for m...

    8.6 Hours Later
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    Jane |Zintro Expert

    Please provide more details . I have experience with CSPs, CSRs, IBs, SAPs etc. ...

    14.7 Hours Later
+16 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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Regulatory Affairs

We are pharmaceuticals company needs a regulatory consultant for the moh - food and pharma.

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    Joseph |Principal-Consultant

    Hi, Thanks for your interest. I can help, provide guidance on ***** food and pharma. Please...

    1.4 Days Later
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    Swanand |Founder & CEO

    Please Call us on +91 ***** ***** and or send us a mail on *****...

    3.8 Days Later
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    Juan | Innovation and Development

    Hello, My name is Juan Ignacio, I am **********irs Advisor at PROCIBUS. My e-ami...

    15.2 Days Later
+6 Other Responses
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