istreamlinesolutions.com
GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., LtdStreamline Solutions
http://www.istreamlinesolutions.com/
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Streamline MedTech (Beijing) Co., Ltd
Yvonne Chen
Room207,2F,Buildin●●●●●●●●●●●●●●●●●●thRoad,HaidianDist
Be●●ng , China, 100084
CN
View this contact
Streamline MedTech (Beijing) Co., Ltd
Yvonne Chen
Room207,2F,Buildin●●●●●●●●●●●●●●●●●●thRoad,HaidianDist
Be●●ng , China, 100084
CN
View this contact
Streamline MedTech (Beijing) Co., Ltd
Yvonne Chen
Room207,2F,Buildin●●●●●●●●●●●●●●●●●●thRoad,HaidianDist
Be●●ng , China, 100084
CN
View this contact
10
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SHANGHAI MEICHENG TECHNOLOGY INFORMATION DEVELOPMENT CO., LTD.
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GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd | istreamlinesolutions.com Reviews
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Resources-GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd
http://www.istreamlinesolutions.com/resouces
US FDA 21 CFR. Part 11: electronic records, electronic signature. Part 50: protect of human subjects. Part 54: financial disclosure by clinical investigators. Part 312: investigational new drug application. Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. Http:/ eur-lex.europa.eu. Http:/ ec.europa.eu. DIRECTIVE 2001/20/ EC, 04-April- 2001. DIRECTIVE 2005/28/ EC, 08-April- 2005. DIRECTIVE 2001/83/EC, 6 November 2001. Http:/ www.sda.gov.cn.
Auditing &Quality Assessment-GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd
http://www.istreamlinesolutions.com/services/show.php?lang=en&id=5
Standard Operating Procedures Development. Regulatory Inspection Readiness &Preparedness. Quality Management System Development and Support. Investigator Site Audits (ISA), including routine and for-cause audits. Vendor Assessments &Audits, including but not limited to Phase I Units, CROs, Laboratories, IP depots and warehouses. Protocol/ Informed Consent Form Audits. Study/ Trial Master File Audits. Clinical Data Audits (Database &TFLs). Clinical Study Reports (CSR) Audits. Telephone: 86 10 6253 0237.
Who We Are -GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd
http://www.istreamlinesolutions.com/about
GCP, GCLP &GLP Services. GMP, GDP and GSP Services. Founded in 2012, is a unique firm specializing in independent quality assurance (QA) consulting in pharmaceutical and life. Consultants provide a full range of QA services in GXP area, including but not limited to:. Good Clinical Laboratory Practice. Good Distribution Practice and Good Supply Practice. We provide you with industry leading audit, training and consultancy services – anywhere in the world. Streamline MedTech (Beijing) Co., Ltd.
News and Events
http://www.istreamlinesolutions.com/news
China: China Redefines the Authority of its Food, Drug and Device Regulatory Agency. China: Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents. India: Indian Supreme Court seeks more oversight of DCGI’s clinical trial approvals. China: Will the Asian Clinical Trial Boom Turn to Bust. China: US FDA: $10M in CR to Add More Capacity in China for Inspections. Streamline MedTech (Beijing) Co., Ltd. Telephone: 86 10 6253 0237.
China: China Redefines the Authority of its Food, Drug and Device Regulatory Agency-GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd
http://www.istreamlinesolutions.com/news/shownews.php?lang=en&id=5
China: China Redefines the Authority of its Food, Drug and Device Regulatory Agency. Ldquo;The Chinese government recently published the final plan to restructure its food, drug and medical device regulatory agency, now named the China Food and Drug Administration (“CFDA”), defining the boundary of its authority and its collaboration with peer agencies in the central government.”. Http:/ www.sidley.com/China-Redefines-the-Authority-of-its-Food-Drug-and-Device-Regulatory-Agency-04-16-2013/.
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GCP audit,china GCP,independent audit,freelance audit-Streamline MedTech (Beijing) Co., Ltd
Investigator Site Audits (ISA), Vendor Assessments &Audits, Protocol, Informed Consent Form Audits, Trial Master File Audits, Clinical Data Audits (Database &TFLs), Clinical Study Reports(CSR) Audits, Due diligent activities . Standard Operating Procedures Development. Process Assessment and Mapping, Gap Analysis, SOPs, Policies and Guidelines Development, SOP Administration. China: China Redefines the Authority of its Food, Drug and Device Regulatory Agency. QA) services in pharmaceutical and life.
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