Regulatory Affairs
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
Information Technology | QA/QC | Regulatory Affairs
Top 5 Misconceptions About Data Integrity
Ron Tetzlaff of PAREXEL Consulting reveals the top five misconceptions management has about data integrityVideos
-
Regulatory Affairs
Elemental Impurity & Risk Assessment
An update on the retirement of USP General Chapter <231>.Paul Mason, Lachman Consultants 07.20.18
-
Industry News | Promotions & Moves | Regulatory Affairs
Slayback Appoints Global Affairs SVP
Joan Janulis is also a noted speaker at various FDA/Industry conferences07.17.18
-
Clinical Trials | Drug Development | Regulatory Affairs
Are EMA-Style Rules for First-in-Human Trials Coming to North America?
Insights from the 2018 DIA Global MeetingBeatrice Setnik, Ph.D., Vice President, Scientific and Clinical Strategy, Early Phase, Syneos Health 07.03.18
-
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
-
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
-
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
-
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
