Validation
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Bio News | Breaking News | Facilities | Industry News | Validation
Emergent BioSolutions Receives BioThrax Approval
German Federal Ministry of Health approves the company’s Michigan facility for large-scale manufacturing02.03.17
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GMPs/GCPs | Inspections | QA/QC | Regulatory Affairs | Validation
Compliance Challenges
The importance of contract compliance during regulatory changeBill Adams, SC&H Group 01.26.17
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Breaking News | Facilities | Industry News | Validation
Sartorius Stedim Biotech Opens New Lab in China
Shanghai site will offer comprehensive validation services for the Chinese market01.12.17
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Validation
Ei, LLC
Ei formulates, develops and manufactures topical liquid and semi-solid Rx, OTC and animal health products for a wide range of clients. The company operates 180,000 square feet of state-of-the-art, FDA Registered and cGMP compliant manufacturing facil…Mike Stenberg, VP, Business Development, Pharma Divsion 12.15.16
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Validation
Chemic Laboratories, Inc.
Chemic Labs is a contract chemistry organization, FDA registered and DEA licensed, servicing the pharmaceutical, medical device, biotech, veterinary medicine and specialty chemicals industries. We offer CMC method development and validation, extracta…lisa walsh, Director, QAU/RA 12.12.16
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Validation
Avomeen Analytical Services
From test method development to after-market support, Avomeen's experienced chemists support all segments of your drug development pipeline. As a full-service CMC/CRO laboratory we provide customized services that aid pharmaceutical researchers,…Nick Graziano, Marketing Director 12.09.16
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Lyophilization | Validation
PaizaBio
With 1.4 billion people, China is the world’s second largest drug market, soon to be #1. CFDA policies now allow for in-country contract manufacturing and expanded access to modern drugs, an unprecedented opportunity for multi-national biopharm…Melanie Lux, PR & Marketing Director 12.08.16
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Validation
Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization delivering proven scientific and operational excellence for solid oral dosage forms. We offer quality formulation development, first-time-in-man for…Emily Almasy, Account Manager 12.07.16
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Validation
Particle Technology Labs
Premier cGMP laboratory, dedicated to particle size and characterization. Non-biased facility provides the most appropriate instrument and result based upon your sample types and needs. Testing includes Particle Size, BET Surface Area, Pore Volume Di…Kelli Hubert, Marketing Manager 12.06.16
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Extractables and Leachables | Validation
NSF Health Sciences
NSF Health Sciences is a GLP and GMP contract laboratory and is FDA-Registered and DEA-Licensed. It offers independent testing and analytical services to pharmaceutical, medical device and biotech companies. Key offerings include: Method Development…Sarah Sparano, Marketing Specialist 11.22.16
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Validation
Pace Analytical Life Sciences
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw mat…James Wheeler, james.wheeler@pacelabs.com 11.18.16
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Validation
Pilgrim Quality Solutions
Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, Pilgrim has automated thousands of processes that ensur…Sandy Carson, MarCom & Events Manager 11.14.16
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Capsules | Supply Chain | Validation
Pharma Tech Industries
.pharmatech{ max-width:740px; margin:auto;} .pharmatech img{ max-width:740px;} .pharmatech h5{ line-height: 20px;} .pharmatech li{ padding-bottom: 10px;} .pharmatech h1, .pharmatech h4, .pharmatech h5, .pharmatech a{ color:#0049…Christopher Dale, Public Relations Director 11.08.16
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Lyophilization | Process Development | Process Validation | Validation | Vials
Ajinomoto Althea, Inc.
.green {background-color:#232c65;color:#ffffff;height:22px;text-align:center;padding-top:2px;width:770px;} .dark {font-weight:bold;text-align:center;} .green a, .green a:hover {text-decoration:none;color:#ffffff;} Who We Are…Kristi Gines, Marketing Strategist 11.07.16
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Cleaning Validation | Validation
GlobePharma, Inc.
GlobePharma, Inc. has been innovating the industry standard for over 20 years. Founded in 1993, GlobePharma introduced the Model I Unit-Dose Powder Sampler. As applications changed, new designs and modifications transformed the sampling line to inclu…Melissa Herko, Dir. Sales & Marketing 11.04.16
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Capsules | Fill/Finish | Injectables | Lyophilization | Validation | Vials
Jubilant HollisterStier Contract Manufacturing & Services
.jubilant{ max-width:740px; margin:auto;} .jubilant img{ max-width:740px;} .jubilant h5{ line-height: 20px;} .jubilant li{ padding :5px; padding-right: 15px;} .jubilant ul{ display: inline-block; padding-left: 15px;} .jubil…Lisa Clark, Coordinator, Marketing & Client Services 11.04.16
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APIs | Process Development | Validation
Rommelag CMO works Holopack Verpackungstechnik GmbH
Rommelag CMO provides you with quick and easy access to BFS technology without having to invest in either the mandatory GMP environment that goes with it or the specialists required to operate and maintain the machines. What we offer is the whole spe…Andreas Hu00e4uu00dfner, Director Marketing 10.28.16
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Process Development | Validation
Maropack AG
Holopack Verpackungstechnik GmbH as well as maropack ag are members of the Hansen-Group, the inventor of the bottelpack aseptic filling machines based on the Blow-Fill-Seal (BFS) technology. We offer secure, economical and individualized solutions fo…Andreas Haeussner, Director Marketing 10.28.16
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APIs | Serialization | Validation
ATL - Ad Tape & Label
ATL, a 60 year old company, specializes in custom labels and the manufacturing and packaging of die cut disposable components for the medical and pharmaceutical industry. Label capabilities include single-ply, extended content, and multi-panel bookle…Gina Butler, Marketing Manager 10.27.16
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APIs | Breaking News | cGMP Manufacture | Facilities | GMPs/GCPs | Industry News | Validation
PCI Synthesis Obtains DEA Registration for Controlled Substance Dev't and Mnf’g
Expands capabilities to handle cGMP development for schedule II, III, IV and V09.15.16
