Regulatory Affairs
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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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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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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 | 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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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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cGMP Manufacture | Clinical Trial Materials | Drug Development | Drug Discovery | Regulatory Affairs
CDMO Outsourcing Trends
iBio’s R. Barry Holtz discusses the trends driving R&D and outsourcing, as well as some of the biggest opportunities for CDMOsOnline Exclusives Kristin Brooks, Contract Pharma 01.11.19
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
CROMSOURCE Appoints Regulatory Services Director
David R. Dills has more than 28 years of experience in the medical device and pharmaceutical industry10.26.18
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APIs | Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Inspections | QA/QC | Regulatory Affairs
Recipharm Audit Results in Licence Restriction
Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk10.25.18
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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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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 | 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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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
