Compliance
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Breaking News | Facilities | Industry News | Inspections
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Breaking News | cGMP Manufacture | Industry News | Inspections
WuXi AppTec Testing Facilities Complete Inspections
Sites in Suzhou and Shanghai receive CNAS and OECD GLP accreditation03.11.19
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Analytical Services | Drug Delivery | Lyophilization | Process Development | Validation
Vetter Development Service
Planning for success. Preclinical through Phase III is a pivotal and unpredictable period for new molecules. Vetter Development Service helps smooth the path to clinic with dedicated support for key stages of development, testing, clinical manufactu…
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Drug Delivery | Validation | Vials
Vetter Commercial Manufacturing
Filling your potential Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 25 years of expertise in high-quality, state-of-the-art a…
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Inspections | Serialization | Vials
Secondary Packaging
Reed-Lane is a full-service contract packager capable of taking your products straight through the final packaging process. We offer a variety of secondary packaging capabilities, featuring final quality inspections serving as your products’…
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Chemistry | Inspections | Microbiology | Process Validation | Regulatory Affairs | Supply Chain | Validation
Support Services
Support Services - our commitment to quality Jubilant HollisterStier provides a full-range of support and services to streamline the manufacturing process. We offer on-site assistance from process qualifications through product release.…
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Validation
Technical Transfer Capabilities
Jubilant HollisterStier has a well-defined and successful system for transferring products from their current facilities to our sites. Products are assigned a Project Manager who is trained and experienced in the complex technical transfer process. O…
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
ICT Opens US Office & Announces Executive Appointments
Office to launch in Rockville, Maryland, with the new hires heading regulatory affairs, business development, and quality assurance03.07.19
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Aseptic Processing | Process Validation | Validation
Emergent Contract Manufacturing & Services
Download our CMO Services Brochure
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Regulatory Affairs
FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition an
A look at how the FDA will administer the transition of NDAs to BLAsKeith Webber, Ph.D., Lachman Consultant Services 03.06.19
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QA/QC | Regulatory Affairs
Are We Embracing FDA’s Messages?
FDA guidance on analytical procedures and methods validation for drugs and biologics.Anthony J. DeStefano, Ph.D. and Tom Kester 03.06.19
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Regulatory Affairs
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
WuXi Biologics Completes EMA GMP Inspection
Becomes the first biologics company in China to do so02.22.19
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
Former FDA Senior Executives Join PAREXEL
The industry veterans will work on the company's Regulatory Consulting group02.15.19
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Breaking News | Industry News | Information Technology | Inspections | QA/QC | Regulatory Affairs | Validation
Top Global Pharma Company to Implement ValGenesis' VLMS
Paperless validation system aims to harmonize and standardize the validation process across all its global sites02.12.19
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Breaking News | Clinical Trials | Industry News | QA/QC
WCG, Prudentia Enter Pharmacovigilance Alliance
Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development01.29.19
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Bio News | Collaborations & Alliances | Industry News | Validation
ValGenesis VLMS Chosen to Digitize Validation Process
New Jersey-based leading contract manufacturer of pharmaceutical drugs chooses company's 100% paperless VLMS01.29.19
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Regulatory Affairs | Serialization
Serialization Compliance: Understanding the Challenges
Pharmaceutical Industry Trails Behind on Serialization for DSCSA.Peter F. Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals, GS1 US 01.25.19
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Bio News | Facilities | Industry News | Regulatory Affairs
Wasdell Granted HPRA for New HQ
Now certified to conduct qualified person (QP) batch certification and release of pharmaceutical products to Europe01.24.19
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Inspections
Upperton Pharma’s Nottingham Site Passes MHRA Inspection
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs01.16.19
