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2010 Regulatory Consulting Project Requests

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For over 5 years, Global Regulatory has been facilitating and centralizing the Regulatory Consulting Outsourcing Process. Below is our Regulatory Request Database listing Incoming Regulatory Consulting Projects which need to be fulfilled ! These Regulatory Requests are received from a variety of sources ranging from large, multinational firms to industry organizations and government agencies actively seeking regulatory services . If your company receives Regulatory Consulting Project Inquiries that it can not fulfill, please refer them to us! If you are an Indendent Regulatory Consultant or Regualtory Consulting Firm that is interested in fulfilling any of these projects, please email us or call 403-770-1994.View Regulatory Consulting Projects Received in 2009

2010 Incoming Regulatory Consulting Projects

Number	Type	Industry	Regulatory Consulting Project Description	Status
10-00096	Training and Education	Life Sciences	South Pacific Government Laboratory needs Biosafety Laboratory for training for 2 on Biosafety in the Laboratory (BSL3). ( read more )..
10-00095	Consulting and Advisory Services	Cosmetics, Personalcare and Toiletries	Cosmetics Company needs FDA consultant who specializes in FDA regulations for the Cosmetic Industry. ( read more )..
10-00094	Registrations, Submissions, Filings and Licenses	Pharmaceuticals	Israel company needs regulatory consultant for Regulatory compliance and Filings for import of Hand Sanitizer to HK and China. ( read more )..
10-00093	Training and Education	Pharmaceuticals	India company needs Quality Consultant for Quality Assurance Training needed for the quality auditing, in brief with respect to QA and regulatory ( read more )..
10-00092	Registrations, Submissions, Filings and Licenses	Cosmetics, Personalcare and Toiletries	US Cosmetics Company looking for consulting help to distribute finished good cosmetic products in Europe, South America (Mexico and Brazil) and Japan ( read more )..
10-00091	Registrations, Submissions, Filings and Licenses	Food and Beverages	Beverage Manufacturer needs Food Regulatory Consultant for Country by country approval for importation and distribution of beverage products ( read more )..
10-00090	Labeling and Advertising	Food and Beverages	Large food company needs Food Regulatory Consultant for regulatory food development consultation and food label review on a regular basis. We also occasionally need advice on other food regulatory matters. ( read more )..
10-00089	Consulting and Advisory Services	Pharmaceuticals	Italy pharmaceutical manufacturer needs regulatory consultant for regulatory services for pharmaceuticals ( read more )..
10-00088	Consulting and Advisory Services	Food and Beverages	Regulatory Consultant needed for advisory services to Certify Pakistan Food Manufacturer according to US FDA Guide Lines ( read more )..
10-00087	Registrations, Submissions, Filings and Licenses	Pharmaceuticals	Regulatory Consultant needed by Austria Pharmaceutical Company for Reimbursement application to Slovakian Ministry of Health for an EMA registered Orpahn Drug ( read more )..
10-00086	Registrations, Submissions, Filings and Licenses	Cosmetics, Personalcare and Toiletries	Israel Cosmetics Company needs consultant expert in registering "Cosmetics with a Claim" with the Israeli Ministry of Health. ( read more )..
10-00085	Consulting and Advisory Services	Pharmaceuticals	Middle East Regualtory Consultant needed to advie on the regulatory norms for import of Sunscreen UVA/UVB products from Australia. Can the products approved by TGA and readily sold in Australia be imported in Middle Eastern countries OR do they need to adhere with EU directives ( read more )..
10-00084	Registrations, Submissions, Filings and Licenses	Pharmaceuticals	INDIA EXCIPIENT MANUFACTURER NEEDS PHARMACEUTICAL CONSULTANT TO ADVISE OF US FDA REGULATION AND EC DIRECTIVE AMENDMENT: NEW US REGULATION RELATED TO FOOD & DRUG FOR EXCIPIENT ( GELATIN & CELLULOSE CAPSLE MANUFACTURER)FOR USA , EUROPE. COLOUR REGULATION FOR ALL COUNTRY OF WORLD FOR FOOD & DRUG EC DIRECTIVE AMMENDMENT ( read more )..
10-00083	Registrations, Submissions, Filings and Licenses	Medical Devices	Brazil Regulatory Expert needed for Registration of products in Brazil: instruments and reagents. ( read more )..
10-00082	Registrations, Submissions, Filings and Licenses	Pharmaceuticals	Pharmaceutical Regulatory expert needed for NDA and drug monograph submissions for a natural product. ( read more )..
10-00081	Export and Import	Cosmetics	Regulatory Expert (must be resident of Japan) needed for Import of USA finished cosmetic and quasi drug products into Japan. Regulatory consultant must be a resident of Japan and speak both Japanese and English. This position will initially be part-time with benefits. Interviews will commence between June 7th - June 18th in Toyko by the hiring manager. ( read more )..
10-00080	Consulting and Advisory Services	Cosmetics	Netherlands, EU cosmetics manufacturer would like to introduce product into USA market and needs advice on US regulations ( read more )..
10-00079	Consulting and Advising	Medical Devices and In-Vitro Diagnostics	Regulatory expert needed advisory services for Class III products for interventional cardiology. All products are CE marked. ( read more )..	Closed
10-00078	Submissions, Registrations, Filings and Licenses	Pharmaceuticals	India Pharma needs Regulatory Consultant for FDA ANDA Submission, Regulatory fillings ( read more )..	Closed
10-00077	Submissions, Registrations, Filings and Licenses	Pharmaceuticals	California Pharmaceutical Corp needs regulatory Consultant for FDA ANDA submission and OTC ANDA submission. ( read more )..
10-00076	Labeling and Advertising	Cosmetics, Toiletries and Personalcare Products	Cosmetics Expert needed for Regulatory review of labeling, packaging and font requirements for cosmetic products ( read more )..	Closed
10-00075	Labeling and Advertising	Nutraceuticals and Dietary Supplements	Regulatory Consultant in France needed to evaluate ingredients and labeling for one food supplement product. ( read more )..
10-00074	Registrations, Submissions, Filings and Licenses	Life Sciences	part time regulatory consultant in Japan needed to oversee building of lab as well as submission of about 18 skus to the Ministry of Health. This person should be bilingual and have worked with cosmetic and quasi drug submission successfully in the past. I will be in japan on the 15th of May for approximately two weeks and and happy to meet and interview any companies or individuals you can provide Chris Seeg ( read more )..	Closed
10-00073	Registrations, Submissions, Filings and Licenses	Medical Devices and In-Vitro Diagnostics	USA based company seeking regulatory consultant who can help us to register our rapid ivd screening devices in Mexico's "FDA" equivalent (COFEPRIS?). ( read more )..	Closed
10-00072	Registrations, Submissions, Filings and Licenses	Consumer Products	NY Company has product registered with US EPA and needs Canada Consultant to register it with Canada PRMA. ( read more )..
10-00071	Registrations, Submissions, Filings and Licenses	Pharmaceuticals	Swiss based MNC manufacturing products in india seeks consultancy services for generic drug product registration in above mentioned countries. please revert with fee details. ( read more )..	Closed
10-00070	Registrations, Submissions, Filings and Licenses	Plastics and Polymers	Turkish representative needed to register our products (resins)that we export to Turkey. Upcoming new legislation requires us to do so. ( read more )..	Closed
10-00069	Registrations, Submissions, Filings and Licenses	Medical Devices and In-Vitro Diagnostics	Medical Device Manufacturer needs FDA Regulatory Consultant for 510K approval Classification Panel: Radiology Diagnostic Devices Classification name: Positron Camera, Class I, 21 CFR � 892.1110 Product Code: IZC Third Party Review Do you have an experiance in such submission? How much do you charge for complete submission or guidance if we want to submit ourselves. Please let us know. ( read more )..	Closed
10-00068	Quality Systems	Medical Devices and In-Vitro Diagnostics	NY Medical Device Manufacturer seeks long term regulatory and quality management consultant, Maintenece of FDA, CE, ISO compliance, update of technical file, Internal quality audits. minimum 2 days at office per week ( read more )..	Closed
10-00067	Labeling and Advertising	Pharmaceuticals	FDA Consultant needed for label review ( read more )..	Closed
10-00066	Regulatory Affairs	Medical Devices and In-Vitro Diagnostics	FDA Consultant needed to Act as the company's independent regulatory representative with FDA (one-year assignment to: Monitor registration of manufacturing establishment with FDA (idem.) 3. Monitor listing of ostomy device with FDA (idem.) 4. Assess suitability of the company's current quality management system in order to ensure compliance with the FDA's Quality System Regulation standards pursuant to 21 CFR Parts 808, 812, and 820 (assist the company in integrating FDA Good Ma ( read more )..	Closed
10-00065	Business Development	Pharmaceuticals	Central Laboratory specializing in clinical trials needs consultant to assist them in moving towards clinical diagnostic in support Pharma companies biomaker development. We would like to get a quote for such service. ( read more )..	Closed
10-00064	Registrations, Submissions and Filings	Clinical Trials	Regulatory Consultant needed for regulatory advice / local document review / submission support for an observational, non-drug trial to be conducted by one of our Sponsors ( read more )..	Closed
10-00063	Audits and Inspections	Nutraceuticals and Dietary Supplements	FDA GMP Consultant needed for cGMPs facility compliance evaluation ( read more )..	Closed
10-00062	Registrations, Submissions and Filings	Clinical Trials	Regulatory Consultant needed to submit protocol in Hungary, Spain, Italy and Austria. We will be able to supply the application for Belgium and France. We do not need the same person to be able to do all of the submissions. ( read more )..
10-00061	Quality Systems	Medical Devices and In-Vitro Diagnostics	Medical Device Manufacturer needs Quality Consultant to assist in sterilizaiton validation to comply with ISO 17664 - Sterilization of medical devices -Need to comply with the above ISO standard. Need help with writing instructions and getting validation for reprocessing of Medical Device accessories. ( read more )..	Closed
10-00060	Registrations, Submissions and Filings	Medical Devices and In-Vitro Diagnostics	Regulatory consultant needed to assist with registrations in Brazil. It would be a bonus if that company had an office in Brazil and could be our in country rep (BRH) as well as provide any input on import/export. ( read more )..	Closed
10-00059	Registrations, Submissions and Filings	Medical Devices and In-Vitro Diagnostics	Medical Device Manufacturer needs Regulatory Consultant for assistance in gaining presence in Mexico, India, China; specifically with the incountry regulatory filings, importation requirements, the need for incountry represenations, registration time lines, costs, etc. ( read more )..	Closed
10-00058	Labeling and Advertising	Life Sciences	Attorney or Regulatory Consultant needed for label claim validation and regulatory guidance in selling our product line into the UAE and other middle eastern countries. We have multi-national business approaching so firms that can do multiple countries are welcome for other business. ( read more )..	Closed
10-00057	Consulting and Advising	Veterinary Medicine	India Universitry needs India Regulatory Consultant for advising on putting into India circulation supplementary feed supplements. ( read more )..	Closed
10-00056	Audits and Inspections	Pharmaceuticals	India Regulatory Consultant needed for pharmaceutical factory inspection ( read more )..	Closed
10-00055	Registrations, Submissions and Filings	Pharmaceuticals	India Regulatory Laboratory needed for Pharmaceutical Regulatory Filings ( read more )..
10-00054	Export and Import	Cosmetics, Toiletries and Personalcare Products	Regulatory Export/Import Agent or Consultant needed to advice on export of finished colour cosmetic brand to the UK and EU. The labeling is in INCI English; ( read more )..	Closed
10-00053	Registrations, Submissions and Filings	Pharmaceuticals	Regulatory Consultant needed for Product registration ( read more )..	Closed
10-00052	Audits and Inspections	Life Sciences	FDA GMP Regulatory Consultant needed for GMP compliance audit ( read more )..	Closed
10-00051	Compliance	Cosmetics, Toiletries and Personalcare Products	Cosmetic Start-up for an eyelash growth product needs cosmetics regulatory consultant to ensure compliance with labeling, laws,etc. ( read more )..	Closed
10-00050	Labeling and Advertising	Construction and Building	Regulatory Consultant or Attorney needed for label review for regulatory compliance ( read more )..	Closed
10-00049	Consulting and Advisory Services	Cosmetics, Toiletries and Personalcare Products	Spain cosmetics manuacturer needs Cosmetics consultant to advise on Controls in bulk and finished cosmetics. Cosmetic In-process samples tested.. Reserve samples os approved lots or batches ( read more )..	Closed
10-00048	Registrations, Submissions and Filings	Pharmaceuticals	Pharmaceutical company needs FDA regulatory affairs consultant to help decide on database lock date for Phase III trial (from a regulatory perspective) and to lead engagement with the FDA for upcoming NDA. 2)Regulatory Operations (NDA writing) ( read more )..	Closed
10-00047	Consulting and Advising	Pharmaceuticals	New York pharmaceutical company needs regulatory consultant to advise on regulatory import and export. ( read more )..	Closed
10-00046	Consulting and Advising	Sports and Entertainment	Canadian company requires consultant to advise on specific methods of testing for hazardous materials found in consumer products. ( read more )..	Closed
10-00045	Registrations,Submissions and Filings	Medical Devices	Medical Deice Consultancy required for India FDA Licensing for import of Class-III mdeical devices into India ( read more )..	Closed
10-00044	Advertising and Labeling	Food and Beverages	Genetics Regulatory Consultant needed to advise on GMO LABELING REQUIREMENTS ( read more )..	Closed
10-00043	Audit and Inspection	Medical Devices and In-Vitro Diagnostics	Medical Device Consultant needed for FDA Internal audit assistance ( read more )..	Closed
10-00042	Validation and Qualification		Saudi Arabia Pharmaceuticals Laboratory needed for validation consultant needed for validation consulting ( read more )..	Closed
10-00042	Registrations,Submissions and Filings	Consumer Products	Canada Biotechnology company needs regulatory consultant to adise on obtain procedure for officially registering tobacco product with US and Canada. We are familiar with requirements for Drugs and biologics but not for Tobacco products. ( read more )..	Closed
10-00041	Registrations,Submissions and Filings	Pharmaceuticals	Regulatory Consultant needed to Support investigation of new drug for potential NADA FDA application. ( read more )..	Closed
10-00040	Audits and Inspections	Pharmaceuticals	Government needs regulatory auditor to assist on good inspection practice of pharmaceutical warehouses (importers and wholesalers), post market surveillance ( read more )..	Closed
10-00039	Marketing	Cosmetics, Toiletries and Personalcare Products	Personal care products manufacture needs consulting for advising on marketing of product lines: 1-Permanent hair remover 2-Ovary of the face and body 3-Freckles and spots remover ( read more )..	Closed
10-00038	Quality Systems	Medical Devices and In-Vitro Diagnostics	Quality Consultant needed for analyzing, recommending and assisting in the preparation of documents and operating procedures, including the Master/Validation Plan(s), for GXP areas such as computer systems, IVD Medical Device manufacturing, packaging, analytical and software development processes. Reviews of existing implemented procedural documents such as equipment, analytical and development may also be required in order to ensure compliance to applicable regulatory standards such as 21 CFR - ( read more )..	Closed
10-00037	Registrations, Submissions and Filings	Pharmaceuticals	INDIA PHARMACEUTICAL MANUFACTURER NEEDS PHARMACEUTICAL REGULATORY CONSULTANT FOR FDA SUBMISSIONS AND EUROPEAN COMMON TECHNICAL DOCUMENT EU CTD ( read more )..	Closed
10-00036	Consulting and Advisory Services	Pharmaceuticals	MIDDLE EAST BASED REGULATORY CONSULTANT TO ADVISE ON PHARMACEUTICAL REGULATORY PROCESS ( read more )..
10-00035	Training and Education	Consumer Products	Looking for an on line health and safety course ( read more )..	Closed
10-00034	Registrations, Submissions and Filings	Medical Devices and In-Vitro Diagnostics	REGULATORY CONSULTANT NEEDED TO FILE SEVERAL ITEMS WITH HEALTH CANADA: NPNs, COSMETICS OR MEDICAL DEVICE (SUCH AS DENTURE TABS). ( read more )..	Closed
10-00033	Consulting and Advisory Services	Pharmaceuticals	Biotech company needs Regulatory Consultant for all activities related to US and International regulatory compliance for investigational and approved drug. includes keeping all reporting and compliance activities for above up to date. Instituting process and controls in order to maintain compliance, Import/export, Annual Reports, Pharmacovigilance ( read more )..	Closed
10-00032	Consulting and Advisory Services	Cosmetics	US Color Cosmetics Company is looking for consulting help in European Cosmetic Directives to sell finished good cosmetic products in Europe. ( read more )..	Closed
10-00031	Registrations, Submissions and Filings	Pharmaceuticals	India Regulatory Consultant and authorised agent needed to register a pharmaceutical product (drug) in India through Marketing Authorisation Holder (MAH) for a pharmaceutical product in India. My understanding is, that we need an authorised agent in India, having a valid licence under the rules to manufacture for sale or having a valid wholesale license for sale or distribution of drugs. ( read more )..
10-00030	Consulting and Advisory Services	Pharmaceuticals	Asia based regulatory consultant needed to advise on regulatory requirements for Regulatory submissions in Japan ( read more )..
10-00029	Consulting and Advisory Services	Medical Devices and In-Vitro Diagnostics	Medical Device Manufacturer seeking a well rounding medical device consultant or consulting team that can advise of gaps in our regulatory compliance for a broad range of regulating bodies. This list includes but is not limited to: FDA, OSHA, EPA, International EU for medical devices, international engineering and safety. Basically we need to know what we don't know. ( read more )..	Closed
10-00028	Consulting and Advisory Services		Europe Natural Products company needs regulatory advices in the labeling and the status of food ingredients in the US market: flavours, colours, ingredients... ( read more )..	Closed
10-00027	Registrations, Submissions and Filings	Veterinary Medicine	Regulatory consultant needed with experience in regulatory filing and importing of veterinary pharmaceuticals into Mexico to assist with registration. ( read more )..	Closed
10-00026	Registrations, Submissions and Filings	Medical Devices and In-Vitro Diagnostics	EU Regulatory Consultant needed for EU CTD (CAPA service required), also EMEA Regulatory filings, also clinical monitoring. ( read more )..	Closed
10-00025	Import and Export	Veterinary Medicine	Import and Export Consultant needed to advise on import of an equine and human nutraceutical from the usa. Both products are manufactured in fda approved labs but do not have fda approval as of yet. The products contain hyaluronan and are considered a drug in canada as far as i can tell. However i wish to sell this unique product because it is light years ahead of the competition. ( read more )..	Closed
10-00024	Consulting and Advisory Services	Pharmaceuticals	Africa based consultant needed for assistance in finding the names of the various government regulatory agencies in Africa e.g Ghana, Kenya, Togo, South Africa etc. ( read more )..
10-00023	Clinical Trials	Pharmaceuticals	Consultant needed for FIM trial (2 sites, appx. 50 pts)of new dermal filler. Consultant will help with country and site selection, and lead process for getting clearance to conduct investigational trial. ( read more )..	Closed
10-00022	Consulting and Advisory Services	Food and Beverages	GMP Consultant needed for food production ( read more )..	Closed
10-00021	Registrations, Submissions and Filings	Chemicals	Regulatory Consultant needed for site registration requests to FDA and DEA and ensuring our compliance with EPA and DOT. ( read more )..	Closed
10-00020	Quality Systems	Pharmaceuticals	USA ISO, GLP, GCP, ASQ certified auditor needed for pre-clinical and clinical bioanalytical laboratory (Method validation, Sample Analysis)and quality systems that support these activities." ( read more )..
10-00019	Compliance	Healthcare	Laboratory consultant needed to assist one of our health care clients with CMS post CLIA validation survey deficiencies." ( read more )..
10-00018	Registrations, Submissions and Filings	Medical Devices and In-Vitro Diagnostics	Start-up "private label' medical syringes importer needs Toronto regulatory consultant for guidance about filing for the necassary licences for USA FDA and Canada (What should the importer do and what should the manufacturer do in case of private labeling. Is ISO licence or simmilar qualifications are necessary and by whom? Any other requirements? How much does it cost? How long does it take? Anything else related we should know about... ( read more )..	Closed
10-00017	Consulting and Advisory Services	Consumer Products	Seeking knowledgeable regulatory consultant to advise on regulatory landscape in Latin America (Mexico, Chile, Columbia, Argentina) for hand sanitizers. ( read more )..	Closed
10-00016	Compliance	Nutraceuticals and Dietary Supplements	Canadian nutraceutical company needs regulatory consultant to advice on compliance . ( read more )..	Closed
10-00015	Consulting and Advisory Services	Pharmaceuticals	Compounding pharmacy needs internationally oriented regulatory affairs pharmaceutical consultant to advise them on going global ( read more )..
10-00014	Consulting and Advisory Services	Transportation	Transportation Consultant needed to answer questions on ISF5 form required for shipments that come from another country and transit through US with final destination outside the US? (i.e. shipment from St. Kitts destine for Mexico that is shipped via Fed Ex and shipment comes into US through Memphis and goes back out to another country)? ( read more )..
10-00013	Registrations, Submissions and Filings	Nutraceuticals and Dietary Supplements	REGULATORY CONSULTANT NEEDED FOR REGISTRATION OF EUROPEAN MADE HERBAL MEDICINE AS IMPORT FINISHED PRODUCT IN CHINA ( read more )..	Closed
10-00012	Registered Agent	Pharmaceuticals	Puerto Rico resident registered agent needed to file license applications/product listings in Puerto Rico ( read more )..
10-00011	Consulting and Advisory Services	Pharmaceuticals	Pharmaceutical Consultants needed for Pharmacovigiliance - Literature Searches for 50 products. 1) perform literature searches, with the aim to ensure that the adverse event reports from the local (Dutch, Belgian, Luxemburg) medical/scientific published literature are detected and reported. 2) to provide the titles of journals we already have or could obtain in portfolio * whether these titles include the journals that are created by patient associations (in Dutch: pati�ntenorganisaties ( read more )..
10-00010	Registrations, Submissions and Filings	Pharmaceuticals	Middle East Regulatory Consultant needed for Facility Design and Saudi FDA approval ( read more )..	Closed
10-00009	Import / Export	Cosmetics, Toiletries and Personalcare Products	Seeking consultants in the Mississauga/Toronto who can guide us through rules on import of homeopathic medicines for personal and commercial use. ( read more )..	Closed
10-00008	Training and Education	Pharmaceuticals	Employee in the Clinical Trial Unit of Biotechnology Regulatory Affairs Department needs Training on regulatory aspects of biotechnology products. ( read more )..
10-00007	Validation and Qualification	Pharmaceuticals	India Pharmaceutical company needs advice on validation of DPT tunnel Question is: What are the Actual time exposures for Vial to depyrogenate , is it depend o Belt length? ( read more )..
10-00006	Registrations, Submissions and Filings	Pharmaceuticals	Experienced Pharmaceutical Consultants needed to file an NDA application in Russia. ( read more )..	Closed
10-00005	Consulting and Advisory Services	Nutraceuticals and Dietary Supplements	South Africa Regulatory Consultant need to adcise on obtainings approvals to market dietary supplements or nutraceuticals ( read more )..	Closed
10-00004	Registrations, Submissions and Filings	Pharmaceuticals	Pharmaceutical Regulatory Consultant needed to determine FDA regulatory filing requirements, liaise with the FDA, guide document filing. ( read more )..	Closed
10-00003	Registrations,Submissions and Filings	Pharmaceuticals	Pharmaceutical Regulatory consultant needed for assistance to submit a duplicate application to Algeria Authorities ( read more )..	Closed
10-00002	Consulting and Adisory Services	Cosmetics	Regulatory Consultant needed to advise on the regulatory requirements needed to develop line of lip gloss ( read more )..
10-00001	Consulting and Advisory Services	Food and Beverages	US Beverage Mfg needs Regulatory Consultant to advice on Beverage regulatory matters. ( read more )..	Closed

See Regulatory Consulting Requests Received in 2010

See Regulatory Consulting Requests Received in 2009

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See Regulatory Consulting Requests Received in 2006

See Regulatory Consulting Requests Received in 2005

Need to find quality , regulatory consultants, attorneys, or other services for industries such as the Pharmaceuticals, Biotechnology, Biopharmaceuticals, Consumer Products, Medical Devices, In-Vitro Diagnostics, Food and Beverage, Nutraceutical, Veterinary Medicine, Electronics, Telecommunications, Aerospace, Defense, Chemical, Life Science , Agriculture, Healthcare, Medical, Nuclear Medicine, or Cosmetics Industries ? Submit Regulatory Requests for Proposals or Contact Global Regulatory at 403-770-1994

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