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미국 현지 FDA 인증허가 전문 | 프로비전 컨설팅 그룹 | - 홈 | provisionfda.net Reviews

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뉴스 & 미디어 - 미국 현지 FDA 인증허가 전문 | 프로비전 컨설팅 그룹 |

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51032;료기기. 51032;약품. 54868;장품. Posted by Provision Consulting Group. On Tuesday, March 17, 2015. Xd504;로비전으로부터 미 FDA OTC 등록인증을 획득한지엠홀딩스의 셀라피. Posted by Provision Consulting Group. On Monday, April 6, 2015. Xd504;로비전으로부터 미 FDA OTC 등록인증을 획득한테라피션 천연탈모방지샴푸. Posted by Provision Consulting Group. On Monday, April 6, 2015. Posted by Provision Consulting Group. On Monday, April 6, 2015. Posted by Provision Consulting Group. On Monday, April 6, 2015. Posted by Provision Consulting Group. On Monday, April 6, 2015.

2

실험대행 서비스 - 미국 현지 FDA 인증허가 전문 | 프로비전 컨설팅 그룹 |

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51032;료기기. 51032;약품. 54868;장품. Heavy Metal TestFood Microbiology. Analytical Chemistry and Materials Characterization. Sterility assurance and microbiology testing. Materials and Chemical Compatibility. Corrosion and Environmental Effects. Simulated / Service Testing. Plastic Properties / Performance. Physical and Chemical Tests. Shelf Life and package Integrity Testing. Clinical Trial Support Services (Viral Vectors). Lab Animal Diagnostic Services. Regulatory and Technical Services.

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의료기기 - 미국 현지 FDA 인증허가 전문 | 프로비전 컨설팅 그룹 |

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51032;료기기. 51032;약품. 54868;장품. 51228;품 분류 및 제품 코드에 대한 컨설팅제공. 50629;체등록과 제품리스팅. 49884;판전 신고서, 510(k) /PMA 준비 및 제출대행. US Agent 로써의 역할감당 및 서비스 제공. FDA 에 관련된 규제 제공. FDA 심사 관련 컨설팅. 51228;품 라벨 검토 및 그래픽 디자인 제공. CGMP 도입을 위한 사전심사, 제품 품질 규제 감사 및 관리 컨설팅. FDA 감사 및 경고장 대응 서비스 (Inspection and Warning Letter Responses). FDA 결정에 대한 상소 (Appeals). 48516;쟁 해결을 위한 기술적 정리 (Organization of dispute resolution process). FDA의 규제. 51068;반적인 승인절차. 46321;급별 특징. 51068;반규제요건만으로&...510(k)가 필요한 제&#544...510(k) 제출시 ...45824;체&#51...

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51032;료기기. 51032;약품. 54868;장품. 49457;분표등의 라벨 검토, 수정 및 그래픽 디자인 제작 서포트. 54728;위 과대 광고등의 misbranding을 피하기 위한 관계문구 교정. OTC drug monograph (기능성 화장품) 성분 검토 및 등록 (SPL format 이용). 51068;반의약품으로 분류되는 기능성 화장품의 업체등록 및 제품 리스팅. 49353;소 및 첨가물 검토. 51228;품 테스팅 서비스 (Laboratory Test). 51068;반 화장품의 VCRP / 등록 서비스. FDA의 규제. FDA의 화장품에 대한 정의. 51032;약품으로 분류되는 화장품 (기능성 화장품). 49849;인요건 충족등을 확인한다. 54532;로비전 컨설팅 그룹. 44540;무시간. 9am - 6pm (USA) / 1am - 10am (Korea).

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51032;료기기. 51032;약품. 54868;장품. OTC drug 등록을 위한 제품의 유효성분 및 함량 검토. OTC drug 등록 (SPL format 이용). 51032;약품 제조/유통업체 등록서비스. 46972;벨 검토 및 제작, 그래픽 디자인 서포트. US agent로써의 역활 감당, 필요한 서비스 제공. 44033;종 실험 대행. 44221;고장 대응. 44592;준 및 시험방법 심사서 작성. 50504;전성 · 유효성 심사서 작성. 54408;목신고/허가 진행. FDA의 규제. 51032;약품에 대한 FDA의 분류. 49888;약신청 (New Drug Application (NDA). 45800;축신약신청 (Abbreviated New Drug Application (ANDA). Over The Counter (OTC Drug Monographs). 46041;물임상실험 (Pre-Clinical Trials). 1 승인 대상. Case Report Tabulations;. 46160...

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Drug - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/drug.html

Food and Beverages/ Dietary Supplements. Consulting Services : Drugs. Domestic / Foreign Drug Establishment Registration. OTC Drug Listings (SPL format). Review and determine active ingredients and strength. Graphic design support for labeling based on FDA regulation. Acts as an US agent. Laboratory testing services to prove safety and effectiveness. What does FDA regulate on Drugs? Abbreviated New Drug Application (ANDA). Over The Counter (OTC Drug Monographs). Investigational New Drug (IND).

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Testings - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/testings.html

Food and Beverages/ Dietary Supplements. Heavy Metal TestFood Microbiology. Sterility assurance and microbiology testing. Materials and Chemical Compatibility. Corrosion and Environmental Effects. Shelf Life and package Integrity Testing. Biologics safety testing: Analytical Methods/ Cell Biology/ Clearance Validation and Cleaning studies/ In viro and In vivo virology/ Microbiology/ Molecular Biology. Clinical Trial Support Services (Viral Vectors). Lab Animal Diagnostic Services.

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Services - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/services.html

Food and Beverages/ Dietary Supplements. Consulting Services : Food and Beverages, Dietary Supplements. USDA VS Import Permits application. Dietary supplement facility regiatrion. Dietary supplement label and ingredient review. What does FDA regulate? The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA. Safety and truthful labeling of all food products including dietary supplements.

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Medical Devices - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/medical-devices.html

Food and Beverages/ Dietary Supplements. Consulting Services: Medical Device. Consult with product classification and product code. FDA Registration and Product Listings. 510(k), PMA Submission Assistance. US Agent Services and Representation. Product label review and graphic design support. Perform critical reviews of prepared submissions. Inspection and Warning Letter Responses. What does FDA regulate? 82-70-8226-3779  Email:. Provision Consulting Group, Inc.

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Cosmetics - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/cosmetics.html

Food and Beverages/ Dietary Supplements. Consulting Services : Cosmetics. Labeling review and graph design support. Review Ingredients and statements to avoid mis-branding. Drug establishment registration and listing. What does FDA regulate? How US. Law Defines Cosmetics. Authorities of FDA on cosmetics. Is It a Cosmetic, a Drug, or Both? Or Is It Soap? FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state req...

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FDA - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/fda.html

Food and Beverages/ Dietary Supplements. The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. What is FDA responsible for? Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled. Human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective. Provision Consulting Group ...

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Food & Beverages/ Dietary Supplements - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/food--beverages-dietary-supplements.html

Food and Beverages/ Dietary Supplements. Consulting Services : Food and Beverages, Dietary Supplements. USDA VS Import Permits application. Dietary supplement facility regiatrion. Dietary supplement label and ingredient review. What does FDA regulate? The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA. Safety and truthful labeling of all food products including dietary supplements.

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About us - FDA Consulting Firm: Provision Consulting Group

http://www.provisionfda.com/about-us.html

Food and Beverages/ Dietary Supplements. Provision Consulting Group, Inc. : Who are we? What do we do? Provision Consulting Group, Inc. is a consulting company that assists businesses with U.S. Food and Drug Administration (FDA) registration and compliance requirements. We offer streamlined solutions to complex procedural issues affecting U.S. FDA-regulated industries, including: medical devices; food and beverages; dietary supplements; over-the-counter drugs and cosmetic products.

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FDA Consulting Firm: Provision Consulting Group - FDA News

http://www.provisionfda.com/fda-news.html

Food and Beverages/ Dietary Supplements. Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2014-N-1251]. Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Dental Devices; Reclassification of Saliva...

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