Compliance

cGMP Manufacture | Industry News | Inspections

Samsung BioLogics Receives Additional FDA Approval

Gains third approval for Plant 2 in 26 months

05.24.18

cGMP Manufacture | Industry News | Regulatory Affairs

Recipharm Plans for Brexit

Establishes a dedicated taskforce to manage the potential impact on ops

05.24.18

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 Affairs

05.22.18

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 readiness

Online Exclusives Tim Wright, Editor 05.18.18

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 excellence

05.14.18

Bio News | Industry News | Inspections

Cytovance Biologics Completes FDA Inspection

The successful five-day process focused on quality systems, facilities, maintenance programs and manufacturing

05.09.18

Regulatory Affairs

India raises bar for clinical trial oversight

New guidelines to bolster institutional ethical committees

S. Harachand, Contributing Editor 05.08.18

Analytical Services | QA/QC

Newsmakers: LSNE

LSNE Expands Capabilities and QC Laboratory Space

Tim Wright, Editor 05.08.18

Regulatory Affairs

GDUFA II: Do You Have a Strategy?

Generic companies continue to face multiple challenges in an ever-increasing competitive market place

Janis A. Picurro, Lachman Consultants 05.08.18

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 approval

05.08.18

Samsung BioLogics Achieves Regulatory Milestone

Becomes first in South Korean pharma industry to achieve ISO 22301 certificate

04.27.18

Bio News | Bioanalytical Services | Industry News | Information Technology | Validation

Blockchain: The Next Big Trend in BioPharma?

Accenture Life Sciences' Carly L. Guenther shares her thoughts on the future of blockchain in supply chain management

Online Exclusives Betsy Louda, Associate Editor 04.13.18

Emergent Completes Market Authorization

For BioThrax (Anthrax Vaccine Adsorbed) in five Concerned Member States (CMS) within the European Union (EU)

04.12.18

Regulatory Affairs

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle: ICH Q12

More than a decade after the birth of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) at a meeting in Brussels hosted by the European Federation of Pharmaceutical Industries and Associatio…

Sharif Ahmed, Lachman Consultants 04.10.18

Analytical Services | Breaking News | Industry News | QA/QC