Compliance
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Bio News | GMPs/GCPs | Industry News | Regulatory Affairs
MHRA Grants MeiraGTx Manufacturer’s Authorization
Enables the manufacture of gene therapy product candidates in current cGMP compliant facility06.21.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Samsung BioLogics Licensed by Health Canada
To manufacture a monoclonal antibody drug substance at its first plant06.21.18
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cGMP Manufacture | Facilities | Industry News | Inspections
Umicore API Facility Passes cGMP Audit
The plant manufactures four oncology APIs produced for global markets according to the latest international guideline06.20.18
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CRO News | Industry News | Promotions & Moves | QA/QC
TFS International Appoints Quality Assurance EVP
Dr Suzanne Pavon brings over 20 years’ global experience in the CRO, biotechnology and pharmaceutical industries06.20.18
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APIs | Breaking News | Collaborations & Alliances | Industry News | Process Validation | Regulatory Affairs
WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo
Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program06.14.18
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Regulatory Affairs | Solid Dosage/Creams/Ointments
Semi-Solid Dosage Forms
Compliance of semi-solid dosages to FDA Stage III Continuous Process VerificationJosé L. Toro, Ph.D., Lachman Consultants 06.12.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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QA/QC | Regulatory Affairs
The Outsourcing Balancing Act
Achieving the best blend of oversight and involvementLeona Fitzgerald and Denise Moody, PPD 06.12.18
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cGMP Manufacture | Industry News | Inspections
Pii Gets Positive Inspection News from FDA and MHRA
Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA06.11.18
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Bio News | cGMP Manufacture | Industry News | Regulatory Affairs | Risk Management
Stellar Announces Positive Third-Party Trial Results
The company's KLH manufacturing methods have achieved robust viral clearance05.29.18
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cGMP Manufacture | Industry News | Inspections
Samsung BioLogics Receives Additional FDA Approval
Gains third approval for Plant 2 in 26 months05.24.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Recipharm Plans for Brexit
Establishes a dedicated taskforce to manage the potential impact on ops05.24.18
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Drug Development | Industry News | Promotions & Moves | Regulatory Affairs
Corbus Announces Key Hires
Dr. Robert Discordia will serve as VP, Pharmaceutical Development & Mfg, and Ross Lobell will serve as VP, Regulatory Affairs05.22.18
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Regulatory Affairs | Serialization
Serialization Readiness: A contract services provider perspective
The serialization challenge and why some contract service providers and brand owners are skeptical of each other's readinessOnline Exclusives Tim Wright, Editor 05.18.18
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Breaking News | Industry News | Promotions & Moves | QA/QC
Melissa Ertl Joins PCI as Quality Head for Philadelphia
To lead quality activities at Philadelphia commercial packaging center of excellence05.14.18
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Bio News | Industry News | Inspections
Cytovance Biologics Completes FDA Inspection
The successful five-day process focused on quality systems, facilities, maintenance programs and manufacturing05.09.18
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Regulatory Affairs
India raises bar for clinical trial oversight
New guidelines to bolster institutional ethical committeesS. Harachand, Contributing Editor 05.08.18
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Analytical Services | QA/QC
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Regulatory Affairs
GDUFA II: Do You Have a Strategy?
Generic companies continue to face multiple challenges in an ever-increasing competitive market placeJanis A. Picurro, Lachman Consultants 05.08.18
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Breaking News | Industry News | Inspections
WuXi STA Changzhou Site Passes First U.S. FDA Inspection
The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval05.08.18
