Helena Champion, consultant, Drug, Drug Quality Assurance, Quality Assurance, Pharmaceutical Quality Assurance, medical device, Regulatory Compliance, FDA, good manufacturing practices, GMP, GLP, test method validation, process validation, commercialization, CMC, audit, auditor, supplier qualification, Drug Expert, FDA Regulations, European regulations, global regulations, device, Champion, Helena, Helen
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Drug Quality Assurance, LLC
Helena Champion
P.O.●●●● 972
Win●●●ter , Massachusetts, 01890
UNITED STATES
View this contact
Drug Quality Assurance, LLC
Helena Champion
P.O.●●●● 972
Win●●●ter , Massachusetts, 01890
UNITED STATES
View this contact
Drug Quality Assurance, LLC
Helena Champion
P.O.●●●● 972
Win●●●ter , Massachusetts, 01890
UNITED STATES
View this contact
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Drug Quality Assurance, LLC | drugqualityassurance.com Reviews
https://drugqualityassurance.com
Helena Champion, consultant, Drug, Drug Quality Assurance, Quality Assurance, Pharmaceutical Quality Assurance, medical device, Regulatory Compliance, FDA, good manufacturing practices, GMP, GLP, test method validation, process validation, commercialization, CMC, audit, auditor, supplier qualification, Drug Expert, FDA Regulations, European regulations, global regulations, device, Champion, Helena, Helen
drugqualityassurance.com
Regulatory Compliance
http://drugqualityassurance.com/Regulatory_Compliance.html
DRUG QUALITY ASSURANCE, LLC. Biopharmaceutical, small molecule, devices. Boston / Cambridge, MA and Palm Beach, FL. We assist clients in:. Complying with GMP regulations for clinical development and clinical trial material – FDA, European, global. GMP compliance for commercial drug manufacture and testing. Evaluate GMP compliance of other companies. Preparation for Pre-Approval Inspections. Inspection and Warning Letter Response and follow up – FDA, European, Global.
Development
http://drugqualityassurance.com/Development.html
DRUG QUALITY ASSURANCE, LLC. Biopharmaceutical, small molecule, devices. Boston / Cambridge, MA and Palm Beach, FL. Quality support for all aspects of drug and device development. Chemistry, Manufacturing and Controls (CMC). Master Batch Record development. Test Method Qualification and Validation. Implement Phase appropriate GMPs and quality systems. Contract Manufacturing Organization Selection and Support:. Suitable for various types of Contractors and Suppliers. We provide realistic, balanced, compre...
Home Page
http://drugqualityassurance.com/Home_Page.html
DRUG QUALITY ASSURANCE, LLC. Biopharmaceutical, small molecule, devices. Boston / Cambridge, MA and Palm Beach, FL. Drug Quality Assurance, LLC provides practical, efficient Quality Assurance and Quality Operations support for drug and medical device. And commercialization and helps you achieve Regulatory Compliance with FDA, European and global current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations. And contract testing laboratories.
Helena Champion
http://drugqualityassurance.com/Helena_Champion.php
DRUG QUALITY ASSURANCE, LLC. Biopharmaceutical, small molecule, devices. Boston / Cambridge, MA and Palm Beach, FL. Helena is an IRCA certified Pharmaceutical Quality Management Systems Lead Auditor /GMP Lead Auditor, an ISO 9001 Auditor and a qualified IPEA Excipient GMP Auditor. Helena has extensive experience leading Quality Audits on drug substance, drug product and medical device manufacturers in the USA and throughout Europe. She is also experienced evaluating US FDA Consent Decrees, Warnin...A Mas...
Quality Assurance
http://drugqualityassurance.com/Quality_Assurance.html
DRUG QUALITY ASSURANCE, LLC. Biopharmaceutical, small molecule, devices. Boston / Cambridge, MA and Palm Beach, FL. Services include all aspects of quality assurance:. Audits - GMP, GLP, GCP due diligence - manufacturers, laboratories, suppliers, CRO's and Clinical Trial sites. GMP Quality Systems and Procedures, Standard Operating Procedures (SOP’s). Quality Assurance oversight of contract services, quality person in plant. Batch Record Review, Disposition, Batch Release.
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Drug Quality Assurance, LLC
Drug Quality Assurance, LLC. Drug Quality Assurance, LLC. Helena Champion, Principal Consultant. Practical Quality support - biotechnology, pharmaceutical drug development, manufacture, testing, clinical trials, commercial. 30 years USA, European, UK experience pharma and biotech manufacture, testing, CMC, hands on product development. Helena was Quality Director at Wyeth Biotech (Pfizer), held senior positions at Biogen Idec, Genzyme, Millipore and Cambridge Isotope Labs /Otsuka. GMP, GLP, GCP. Master V...
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Drug Questions? Answered.
Friday, June 27, 2014. How do I dispose of unwanted medication? Consider this statistic, only 4.7% of children that abuse prescription drugs get them from a drug dealer, stranger or the internet. Where do the other 95.3% find them? Throughout the United States. The local independent pharmacy in my town allows customers to return unwanted and expired non-controlled. Check the website RxDrugDropBox. For availability of a medication drop box at your local police department. Controlled substances, such a...
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