Compliance
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Regulatory Affairs
Reporting CPPs to FDA
Importance of identifying critical process parameters in original submissions to FDA.Aloka Srinivasan, Ph.D. Lachman, Consultant Services 10.10.18
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Regulatory Affairs | Serialization
Serialization & EU FMD Readiness
Executives from Recipharm and TraceLink provide insight into a recent report from FutureLink Munich 2018Tim Wright, Editor, Contract Pharma 10.10.18
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Breaking News | Industry News | QA/QC
USP Launches Impurities for Development Program
Aims to help manufacturers meet quality standards and regulatory requirements to control impurities10.10.18
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Logistics | Process Validation | QA/QC
Nulogy Launches Quality & Compliance Solution
Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the marketOnline Exclusives10.04.18
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Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News | Validation
Samsung BioLogics' Plant 3 Starts Production
World’s largest single bio manufacturing plant is cGMP ready and started production (OOF, out of freezing) after validation10.01.18
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APIs | Breaking News | Facilities | Industry News | Inspections
Asymchem Passes FDA Inspection at API Mfg. Site
Reports successful FDA inspection of Tianjin 2 development and commercial manufacturing facility with no Form 483 issued09.14.18
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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, Customer Service Manager 09.14.18
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Bio News | Collaborations & Alliances | Industry News | Regulatory Affairs
Recipharm Receives EMVO Approval
The connection, facilitated by strategic partner TraceLink is to to submit serialization data to the European Hub09.13.18
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Regulatory Affairs
FDA and Field Alert Reports
Analysis of “Field Alert Report Submission Questions and Answers Guidance for Industry”Constance Richard-Math, Lachman Consultants 09.11.18
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Bio News | Breaking News | Facilities | Industry News | Inspections
ADMA Biologics Reports Updated Compliance Status
FDA inspection database confirms VAI status of Boca Raton, FL facility09.05.18
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Bio News | Collaborations & Alliances | Drug Development | Industry News | Validation
Horizon Discovery Partners for Target Identification
With global pharma leader to co-develop and apply a novel cutting-edge research tool for target identification and validation08.28.18
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APIs | Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Novasep Announces Successful FDA Inspection
At its API development and manufacturing site in Chasse-sur-Rhône, France08.27.18
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | Regulatory Affairs
CCAB, ImmunoBiochem Partner for Cancer
CCAB to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic08.23.18
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Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
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Drug Development | Regulatory Affairs
Why Otsuka Outsourced Regulatory Affairs
How outsourcing regulatory affairs gave Otsuka flexibility to move products through the development process faster.Online Exclusives Kristin Brooks, Managing Editor 08.09.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Absorption Systems' ACF Bioservices Certified by MHRA
Certification warrants that facility is in compliance with the cGMP requirements after an April 2018 inspection by the MHRA08.07.18
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Bio News | Biologics, Proteins, Vaccines | QA/QC
Avalon GloboCare Forms Strategic CAR-T Pact
Aims to co-develop bio-production and standardization procedures for CAR-T therapy in accordance with standards08.07.18
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QA/QC | Regulatory Affairs
Data Integrity Awareness in Pharma
Most data integrity violations are just a result of simple lack of knowledge, negligence, or even a wrong management strategyVideos
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Collaborations & Alliances | Regulatory Affairs | Serialization
Abdi Ibrahim Selects rfxcel for FMD Compliance
Will support serialization software to ensure compliance with current & future international legislative requirements08.02.18
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APIs | Bio News | Facilities | Industry News | Inspections
WuXi STA Site Passes Fourth Inspection
API manufacturing facility at Jinshan also passed FDA inspection in 2013, 2014 and 201607.26.18
