Affordably Source Securities And Exchange Commission (sec) Experts and Industry Participants for Market Research, Diligence and Projects

Submit an anonymous Project Description -- Start receiving responses within a few hours

Have a need? Explain it here






How Zintro Works

  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
  3. 3. You can communicate back and forth, qualify each other, connect and pay fees to Experts through Zintro.
  4. Zintro is free, anonymous and without obligation.

Loved by Thousands

Loved by thousands logos

Need Help?A phone icon1-877-236-7016

Recent Securities And Exchange Commission (sec) Inquiries

Area Icon

Us Agency Consolidation

Us agency consolidation contribute to the zintro blog! i write the zintro blog. I am looking for your expert opinion on the question below and a written response that is one to three paragraphs long. Your response may be used in an article that i will write and post on the zintro site. If it is used, you will be named in the article and a link to your expert profile will be included. Your contribution is voluntary (there is no payment involved). Question: president obama recently announced that he is seeing congressional approval to consolidate six government agencies that interact with businesses and trade. He also made the head of the small business administration a cabinet post. What are your thoughts on these consolidations? Will they help or hinder small business progress or relationships with the government? This is a great marketing opportunity to get your name and expert opinion published on our blog. Here is a sample: http://blog.Zintro.Com/2012/01/16/keystone-xl-pipeline-pros-and-cons/ if you are interested, please send me your response via znotes in the next day or two. Please include your full name and credentials. If you have any questions, please let me know. Thank you! maureen aylward

  1. Profile Picture

    Ann |Consultant

    ***** agencies is long overdue, and I'm fully supportive of this move. How long a piece ...

    6 Minutes Later
  2. Profile Picture

    Donald |Managing Partner

    Making the Small Business Administration a Cabinet Level Position is a real and serious move-whether...

    48 Minutes Later
  3. Profile Picture

    Nicolas |Senior Vice President

    President Obama's proposal to *****ral independent agencies into the US Department of Com...

    1.1 Hours Later
+8 Other Responses
Area Icon

Medical Device Regulatory Affairs & Quality Assurance

To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered. Job responsibilities: manage daily activities of regulatory affairs and quality assurance personnel implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products qualifications: **must haves** bachelor’s degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required. Must have direct, lead role fda/iso audit experience must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process. Location: greater philadelphia area, pa

  1. Profile Picture

    Monther |President

    Hi, I'll be glad to assist you with all your *****irs tasks/activities. I have over 20 yea...

    4.2 Hours Later
  2. Profile Picture

    Sharon |Principal Consultant

    Attached please my resume for your review and consideration. Please contact me to discuss this caree...

    7.9 Hours Later
  3. Profile Picture

    RONOC IP |Owner

    Resume attached...

    19.3 Hours Later
+25 Other Responses
Area Icon

E-commerce Scale Effects In Online Pharmacy

We are looking to speak with multiple experts in assessing the scale effects of e-commerce operations (esp. Fulfillment), ideally for online-pharmacy such as asos, zalando, douglas, dm. We want to have a better understanding of the overall e-commerce operations, brands, positioning, competitive dynamics, trade vs. Ecommerce, etc. This would be for a 1-hour paid phone consult. Please respond with a few brief statements of your background and relevance to this space with your short answers to the points below: 1) can you share your thoughts on the key success drivers of a large-scale online-pharmacies (10-20m+ packages per annum)? Please explain briefly. 2.) what is the extent of your involvement in operations / logistics focus in e-commerce (pick & pack, shipment, etc.)? Please explain briefly. ***referrals are highly appreciated

  1. Profile Picture

    Joel |CEO

    Hello, I am a successuful Pharmacist and Consultant Pharmacist.I have owned my owned Pharmacy's for ...

    1.5 Hours Later
  2. Profile Picture

    Rachael |Zintro Expert

    I am a pharmacist for a specialty mail order pharmacy with 5 year experience at this particular faci...

    3.4 Hours Later
  3. Profile Picture

    René |Director

    1) Can you share your thoughts on the key success drivers of online-pharmacies? key success driver ...

    1 Day Later
+15 Other Responses
Area Icon

Biopharmaceutical Regulatory Filing

I am writing on behalf of a consulting firm that conducts expert interviews in support of industry-wide studies for many of the world's fortune 1000 companies. We help businesses answer questions by engaging with the world’s most relevant experts. So far we have delivered over 750 studies with input from over 15,000 individuals. We are an authorized zintro partner. For a current study, we would like to speak with someone who has extensive biopharmaceutical regulatory filing experience and can provide insight into qms, equipment, consumables, protocols/procedures, incoming/outgoing specifications, environmental conditions, etc. Please see below for some sample questions and topics that we are interested in discussing: - if multiple, identical sites were deployed into key geographies, could they be interchangeably used to supply an approved biologic into markets where regulatory approval had been achieved? - what degree of freedom to move site of manufacturing exists during the clinical trial process? - if possible, what would be required to enable this degree of operational flexibility (i.E., allowing the biomanufacturer to push production to any of the identical sites based upon a variety of factors)? - which regulatory agencies would enable this approach? Which would not? Specific to the biopark: - who owns the qms for a drug made in biopark? - how is it to be managed in respect of shared components (e.G., wfi)? - how would required changes or audit concerns on one company affect other companies on site? Please note that we are only interested in your personal point of view and expert insight and are not seeking any confidential information. We are scheduling 45-60 minute discussions with experts this and next week and are happy to offer a negotiable usd 250 compensation for each interview. Please note that we are handling the standard zintro fee separately, hence the expert is not involved in paying this. We would welcome any referrals to other relevant experts as well. Best regards, elianny

  1. Profile Picture

    Polina |Oversight & Monitoring Lead, Health Care

    Hi Elianny, We spoke before and I actually support ***** Review and am very familiar with...

    7 Hours Later
  2. Profile Picture

    Jayant |Pharma Reg Expert

    Hello Elianny, I would be happy to assist you in the decision making on this project. Please go thr...

    8.3 Hours Later
  3. Profile Picture

    Dr Venkat |Global Consultant

    Elianny, I can answer some of your questions and also refer my colleagues from Americas ,APAC,MIddle...

    9.6 Hours Later
+7 Other Responses
Area Icon

Sec Filing

I'm looking for an sec filing consultant with experience with activedisclosure 2.0.

  1. Profile Picture

    Shaun |Vice President

    Hi My team worked on a project in this industry last year. Can you provide full scope and the timeli...

    2.5 Hours Later
  2. Profile Picture

    Henry |Business Analyst/Project Manager/Technol

    Thanks for contacting me but I don't have enough experience to help you....

    5.1 Hours Later
  3. Profile Picture

    Peter |

    Yes I've worked extensively with RRD's ActiveDisclosure tool and have compiled and filed many SEC do...

    1.5 Days Later
+8 Other Responses
Area Icon

Mhra Compliance

Need help on software as a medical device(mhra) class 1, class 2a regulatory compliance consultant needed in the uk

  1. Profile Picture

    Daniel |CEO & President

    HELLO We have an FDA and Quality Management Systems expert in our group. We can send you an mutual N...

    2.3 Hours Later
  2. Profile Picture

    Parul |Regulatory Consultant, Elexes Inc.

    I have prepared many *****issions on behalf of Medical Device and software companies and s...

    1.5 Days Later
  3. Profile Picture

    Marcus |Medical Device Regulatory Professional

    Dear Sir/Madam I have vast experience dealing with software as well as Class I and Class 2a medical...

    52.8 Days Later
+3 Other Responses
Area Icon

Director Of Clinical Operations

Director of clinical operations: (full-time, onsite position) as a key member of the management team, the director of clinical operations will oversee studies on our novel bioelectronic medicine platform, providing comprehensive clinical evidence to support marketing application submissions. Reporting to the chief medical officer, the individual will be expected to:  work closely with the medical, regulatory, quality, and r&d teams on the design of our clinical development program, and the plan for program execution  develop and manage operational plans for individual studies within the clinical development plan  author documents including clinical study protocols, investigator’s brochures and clinical study reports, and collaborate in the preparation of manuscripts and external presentations  manage clinical trials service providers and suppliers and interact closely with investigative sites,  develop sops and guidelines, and ensure compliance with regulatory agency requirements  recruit, hire, and manage additional clinical team members  lead, collaborate with, and mentor employees in other functional areas  qualifications:  the ideal director of clinical operations candidate will have:  10 years of experience in a fast-paced, demanding technical organization.  experience in clinical development of a class iii medical device is strongly preferred. Experience in the inflammation therapeutic area or closely related areas is a plus.  experience working with fda and other global regulatory agencies is preferred.  a bs or equivalent degree is required and a masters or doctoral level degree is preferred. Please attach your cv here to apply.

  1. Profile Picture

    Tom |Chairman Emeritus

    Of course I would need more details, but I am interested in hearing more....

    1.4 Hours Later
  2. Profile Picture

    Insynergy |Executive Director, Clinical Trials.

    I'm qualified by ***** experience for this position. I'm interested but need more informatio...

    6 Hours Later
  3. Profile Picture

    Andrew |Director Business Development & Operatio

    January 28, 2016 Re: Director of Clinical ***** Dear Human Resources Director: Please allow...

    7.3 Hours Later
+13 Other Responses
Area Icon

Regulatory

We are a green technology company committed to improving the productivity and decreasing the environmental impact of modern agriculture. We are looking to hire a full-time regulatory specialist. The regulatory specialist job exists to develop new product registrations and to support existing product registrations on a global basis, under the guidance of the senior director of regulatory affairs. The role includes both globally strategic and tactical elements. Primary responsibilities: • understand and stay abreast of product regulations • harmonize existing product registrations amidst a changing regulatory landscape • track registration status and private labels on a global basis • prepare and lead document submission to regulatory agencies • consolidate and organize registration documentation • develop and maintain process for document archiving • lead regulatory project work such as regulatory competitive assessments and regulatory guideline related research • participate and/or lead cross functional teams • attend and deliver recommendations from key industry associations • partner with manufacturing product development and commercial organizations in order to drive regulatory alignment • develop and draft new data packages for regulatory submission • proved global support for organic certifications • serve as contact point for regulatory consultants qualifications include: • bs or ms in scientific field such as biology, chemistry or agronomy • experience in agrochemical, biotechnology or fertilizer product development. • at least 3 years of experience in regulatory sciences or regulatory affairs • demonstrated track record in managing global projects • experience leading cross functional teams • basic understanding of how intellectual property is developed and managed • skill includes; technical aptitude, organizational skills, interpersonal skills, strong communication skills, initiative • experience working outside of the u.S. • travel 5-10% of time. This position is based in the sacramento area and reports to senior director of regulatory affairs. Excellent comp package - dependent on experience. Details to be presented during interview process. *please attach your cv for our review.

  1. Profile Picture

    Meghal |

    Hi, I am interested. I have experience in the following: • Responsible for the day to day regulator...

    3.9 Days Later
  2. Profile Picture

    New |

    Hi, I am interested. Please check my experience SUMMARY: • *****vidual with ...

    3.9 Days Later
  3. Profile Picture

    New |

    Hi, I am interested. I am Quality Control ***** I have experience in: • Carry out release t...

    3.9 Days Later
+19 Other Responses
Area Icon

Medicine And Healthcare Products Regulatory Agency

Mhra experience preferred in a validation environment. Must have life sciences experience. Plus if they have more than 5 years in field

  1. Profile Picture

    Donald |Vice President of Operations

    30 years of experience in pharma/biotech manufacturing. US and EU. Knowledge of FDA and EMA requir...

    2.6 Hours Later
  2. Profile Picture

    Rogerio |Researcher

    I would like to help. ...

    4.1 Hours Later
  3. Profile Picture

    Ken |Director

    null...

    1 Day Later
+3 Other Responses
Area Icon

Mhra Standards

We need a consultant to upgrade our facility to mhra standard. We also have option to build the new one. Hemant

  1. Profile Picture

    Vijay |Clinical Project Manager

    Dear Hemant, Where do you have your current facility located? Did you have any previous inspection/...

    21.9 Hours Later
  2. Profile Picture

    Magnus |Consultant

    Dear Hemant, I have designed, built and upgraded to MHRA, FDA standards several pharmaceutical plant...

    23 Hours Later
  3. Profile Picture

    Dr Venkat |Global Consultant

    I am the Chairman of UK based Helix Research Center Ltd and we offer GMP Consulting service as well....

    23.5 Hours Later
+3 Other Responses
Area Icon

Equity Investor

Our company has several public companies in our control and one of which, we have structured the re-org and all associated resources to bring the company current, including two years of filings to the sec and any/all regulatory agencies. The group® has positioned all the resources including preparation of all financials for audits and filings upon receipt of funds and we are well versed in the otcmarkets to accomplish the task. The opportunity is to loan/fund/partner with the group®, and provide, $65k to bring the company current with all regulatory agencies filings and two years of audited financials. At this point we would file a 15c211, however, if pubco had an intended target, then we could file two years of the private company’s financials, w/w.O audits with the 15c211 which would expedite and, simplify the process including the economics. Once current with the sec the shell is worth ~$400,000 we can provide the majority share control block of the public company as collateral. Also, we would entertain having an equity partner as well.

  1. Profile Picture

    Spencer |Managing Director

    Equity Investor, please give us a call. We may be able to help you. Thanks Spencer...

    25.9 Days Later
+1 Other Responses
Area Icon

Clinical Regulatory Affairs In California

This is a new opportunity for a senior manager / associate director, regulatory affairs (clinical) full-time position in california. Overview: manage and lead regulatory activities for assigned programs to ensure alignment and compliance with local, federal, and other regional registration requirements, as well as with company policies. At the senior manager level, implement plans for timely submission and approval of preclinical submissions, applications for clinical trials, marketing applications, etc, and provide regulatory guidance and support to project teams. The senior manager may provide guidance to members of the regulatory team. At the associate director level, the incumbent will develop and implement regulatory strategies for timely submission and approval of preclinical submissions, applications for clinical trials, and marketing applications, and provide regulatory leadership to project teams. The associate director will possess the regulatory expertise to translate regulatory requirements into practical, workable plans and interact with regulatory agencies. Responsibilities: -partner with project leaders, department heads, and project teams to collaboratively implement the company’s regulatory strategies. -the associate director level incumbent will provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters. -provide us, eu, and/or global operational input and coordination of regulatory strategies. -manage the assembly, review, and approval of assigned regulatory dossiers and documents (content) and the final sign-off of regulatory submissions. -provide input to target labeling content (mds, smpc, us package insert, container packaging, etc). -manage the regulatory work of cros and consultants. Qualifications: -a ba/bs with 6+ years’ clinical regulatory affairs experience, with 2 years in a management role. The associate director level will have 8+ years’ experience and 3+ years’ management experience with lead clinical regulatory responsibilities. -broad to in-depth understanding of fda drug and biologic regulations and guidelines, particularly clinical development. -previous experience working with cder and/or cber, some aplb/ddmac exposure desirable. -experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements. -experience interfacing with relevant regulatory authorities highly preferred. -experience in project team management. -fluent knowledge of all stages of pharmaceutical drug development with emphasis in clinical development and operations compliance and documentation. Contact us here on zintro for more details.

  1. Profile Picture

    Alfred |Zintro Expert

    Part time position desired...

    1.7 Days Later
  2. Profile Picture

    Anthony |Independent Consultant

    Is this posted by Michael Collins?...

    5.5 Days Later
  3. Profile Picture

    Kristen |Zintro Expert

    I would be interested in this position. Can you tell me a little more about the company?...

    39.6 Days Later
+11 Other Responses
See More Inquiries

Top Securities And Exchange Commission (sec) Experts

See More Experts
Share
LinkedInTwitterFacebookGoogle+