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Recent Regulatory Compliance Inquiries

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Regulatory Compliance In Latin America

We have been engaged by a cpg company to provide a list of consulting firms/agencies that are managing regulatory compliance services in latin american countries focusing in 1. Guatemala 2. Ecuador 3. Costa rica 4.Panama. Below are the list of deliverables: • consulting firms providing regulatory compliance services for the countries of focus mention above • industry best practices in sourcing regulatory compliance services • engagement models (using different consulting firm for each country or one consolidated supplier for entire latam region) • cost saving opportunities thank you.

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    Medical Device Regulatory Compliance

    Hi i am looking for some advice in relation to if a product could be classed as a medical device or not, particularly in eurpoe. It is an all natural cream used in the treatment of the symptons caused by haemorrhoids such as, pain, itching and inflamation. Any help would be greatly appreciated. Many thanks

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      Les |Principal

      Based on this initial information, it appears that it would be a medical device. Please email at fd...

      1 Minute Later
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      Brian |Chief Regulatory Consultant

      Happy to help. In order to do so, I'd need to understand the product's mechanism of action. If it'...

      23 Minutes Later
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      Majid |President

      Hello, I can help you with this request please send me your contact ***** I can speak to yo...

      36 Minutes Later
    +10 Other Responses
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    Consumer Lending Regulatory Compliance

    We are a startup who needs an independent subject matter expert (not our legal representation) on consumer lending regulatory compliance to be a consultant for an independent audit we are having performed.

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      Peter |Managing Partner

      I would be willing to have a quick (15 minute) free introductory call to learn more about your needs...

      38 Minutes Later
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      David |Director and Principal Consultant

      I may be able to help or may be able to suggets someone who can - but we need to know in which juris...

      8.5 Hours Later
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      Kevin |Owner

      I am very interested in getting additional background ***** this project. I am extremely we...

      9.5 Hours Later
    +4 Other Responses
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    Electrical Compliance

    As i have recently sold my house i require a certificate of compliance that can be verified (ie issued by a registered electrician and accepted by the municipality) to be supplied by a reputable qualified electrician. I would like to understand the process and the costs of each step of the process.

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      James |Principal

      I am assuming that this is a *****ty/city requirement. I will be happy to talk to you about th...

      44 Minutes Later
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      Christopher |Electrical Administrator

      This depends on the municipality, but you are required to have an electrical ***** master...

      2.2 Hours Later
    +3 Other Responses
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    Fda Regulatory Compliance

    I am looking for experts with more than 20 years of experience in fda regulatory compliance to conduct seminars. Please drop me a message or reply to this inquiry

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      Dean |Principal Human Factors Engineer

      My expertise is in *****n factors activities and reports that assess use error. OEM's need...

      31 Minutes Later
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      Michael |Regulatory Project Manager

      *****irs *****ident, Stephen Goldner, has over 40 years industry experience and ...

      38 Minutes Later
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      Cynthia |Executive Vice-President

      I am sire I can be of assistance. I have 35 years of experience working in all aspects of FDA Compl...

      40 Minutes Later
    +24 Other Responses
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    International Regulatory Compliance

    I work for a consumer products manufacturing company, that specializes in manufacturing soap and detergent. Most of our products are sold only in north america but we have a customer who is currently distributing products in the united kingdom, taiwan, south korea, japan and australia. They are looking to expand distribution into france and spain as well. In order to provide support for our customer, we are looking for a consultant to help us with some export and global compliance projects. The projects may encompass: formula compliance including hazard classification, labeling compliance and possibly insight into consumer habits in these countries. Please confirm whether or not these services are offered by your company. If you are able to meet these needs please provide me with information regarding next steps as we are looking for input as soon as possible.

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      Rita |Principle

      Unfortunately, I am not familiars with compliance issues for your ***** products....

      2.1 Hours Later
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      Maruf |Group Manager, Marketing and Sales

      Sir, I am Maruf Hasan. I am an expert in promoting personal care products. I can help you to analyz...

      5.2 Hours Later
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      Rossano |International Business Consultant and Ac

      It sounds to me that you want someone, who has done Marketing Research on Consumer in emerging or de...

      10.9 Hours Later
    +5 Other Responses
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    Nuclear Regulatory Compliance

    Need an expert consultant/witness with experience in regulatory compliance at nuclear facilities (clean-up). Specifically neshaps compliance under 40 cfr 61

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      Larry |President

      I am a *****rt that worked at the US EPA and US DOE on numerous nuclear waste clean-ups an...

      1.3 Days Later
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      Anthony |Systems Simulation and Regulatory Compli

      I have experience in 10 CFR 50 Nuclear **********ers. I'm confident that I ...

      44.1 Days Later
    +2 Other Responses
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    Oil And Gas Compliance

    We are looking for an independent consultant having more than 15 years of experience in dealing with oil and gas contracts and who can help us in an oil and gas contract compliance audit for one of our clients in malaysia. Interested industry experts may reach out to us via zintro.

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      Lyn |Consultant

      I have over 40 years experience at senior level in the Oil and Gas Industry with both end user and v...

      56 Minutes Later
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      Marcel |Managing Partner

      MSi-Support has over 20 years of experience. On request we will send you the CV of our Contract Lawy...

      1.4 Hours Later
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      Gary |Founder Owner

      33 years of global oil and gas commercial and engineering Experience 10 years oil and gas Co 23 yea...

      2.9 Hours Later
    +19 Other Responses
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    Regulatory Compliance

    We have an immediate opening for a full-time regulatory compliance specialist at our facility in south austin, texas. ***please submit your reply along with your cv/resume attached as a word doc/pdf file over here. ***job summary: we are a private laboratory providing stem cell processing and storage services. This position is responsible for reading and interpreting all applicable international, federal, state and local regulations for our industry and advising senior management on recommended actions to insure compliance with those regulations. The primary regulations applied to us are cfr title 21 section 2171.10 however there are others which are also relevant. ***specific knowledge of these are not required however it would provide a large advantage over other applicants. ***general knowledge and experience with fda, cglp, cgtp, osha, iso, and other regulatory structure is required. In addition to usa fda regulatory compliance this position would help to insure our compliance with the uk human tissue authority (hta) regulations as they apply to our industry. ***a successful candidate will have the following attributes:  some biological lab experience including mammalian cell culture is preferred  quality assurance experience is required.  regulatory compliance experience require however extensive experience working in a regulated lab may substitute depending on the circumstances.  have a bs degree with 5 year of relevant experience or an advanced degree with 2 year of relevant experience.  some previous personnel management experience is desired but not required.  be familiar with reading and writing sop’s, capa’s and risk analysis.  be familiar with conducting internal regulatory audits. ***please attach your cv/resume here to apply. ***note this full-time, on-site job position does not provide visa sponsorship.

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      Mark |Chairman & CEO

      I have extensive hands-on experience in *****liance over 24 yrs with US/EU pharma compani...

      1 Day Later
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      samson |QHSE Leader and ISO(HSE) Lead auditor

      I have wide experience in developing, interpreting and implementing policies, procedures and work in...

      1.1 Days Later
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      Shivani |

      Dear Sir/Madam, I am writing to apply for Clinical Trial Coordinator, which I found through Simply...

      1.6 Days Later
    +74 Other Responses
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    Regulatory Compliance

    Designing new learning tv remote urc option 1 - ir only option 2 a ir + rf need to know what compliance and testing is required??

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      John |Director

      Hi, Compliance and testing will depend on target market e.g. North America and Europe. FCC complian...

      18 Minutes Later
    +1 Other Responses
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    Pharma & Biotech Regulation And Compliance

    We are a small private equity fund looking for corporate attorneys from "white shoe" firms who have experience engaging with clients in the pharmaceutical and/or medical device industries regarding kol compliance (as regulated by the fda, oig, and/or us doj or similar entities in other countries). Have questions about trends concerning regulation of kol engagement, particularly with regard to "anti-kickback" legislation and the need for companies to monitor and track their kol engagements and payments in particular.

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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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