Compliance

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 APIs

01.16.19

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 CDMOs

Online Exclusives Kristin Brooks, Contract Pharma 01.11.19

Breaking News | Industry News | Inspections

Akorn Receives FDA Warning Letter

Akorn is working collaboratively with the FDA to resolve all issues related to an inspection of its Decatur, IL manufacturing facility

01.09.19

Blockchain Technology: How Much Money Will It Save?

GlobalBlock Co-Founder, David Thomas, shares insight about the future of Blockchain Technology in the Pharmaceutical industry

Online Exclusives Betsy Louda, Associate Editor 01.08.19

QA/QC

Three Ways Quality Can Impact a Business’s Bottom Line

The Quality function today is tasked with helping to improve overall company performance

Stephen McCarthy, Vice President of Digital Innovation at Sparta Systems 12.05.18

Cleaning Validation | Validation

Compliance Insight, Inc. specializes in hands-on FDA Regulatory and Quality Assurance consulting and training for the pharmaceutical, dietary supplement, medical device, chemical, cosmetics, bio-technology and food industries worldwide. Services incl…

Cindy Ipach, President 11.28.18

Clinical Trials | Drug Development | GMPs/GCPs | Information Technology

Update on ICH E6 R2 Guideline for GCP

Patrick Hughes of CluePoints discusses opportunities and advantages of the new guidance and considers possible limitations

Patrick Hughes, Chief Commercial Officer, CluePoints 11.27.18

Chemistry | Methods Development | Microbiology | Validation

Pace Analytical Life Sciences, LLC

Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw mat…

James Wheeler, james.wheeler@pacelabs.com 11.21.18

APIs | Breaking News | Facilities | Industry News | Inspections

CordenPharma Completes SafeBridge Recertification

Potent Compound Recertification Audit was conducted at Colorado site

11.20.18

APIs | Serialization | Validation

ATL - Ad Tape & Label

ATL, a 60 year old company, specializes in custom labels and the manufacturing and packaging of die cut disposable components for the medical and pharmaceutical industry. Label capabilities include single-ply, extended content, and multi-panel bookle…

Gina Butler, Marketing Manager 11.16.18

APIs | Process Development | Validation

Rommelag CMO - Holopack Verpackungstechnik GmbH

Rommelag CMO provides you with quick and easy access to BFS technology without having to invest in either the mandatory GMP environment that goes with it or the specialists required to operate and maintain the machines. What we offer is the whole spe…

Andreas Haeussner, Director Marketing 11.15.18

Process Development | Validation

Rommelag CMO - Maropack AG

Holopack Verpackungstechnik GmbH as well as maropack ag are members of the Hansen-Group, the inventor of the bottelpack aseptic filling machines based on the Blow-Fill-Seal (BFS) technology. We offer secure, economical and individualized solutions fo…

Andreas Haeussner, Director Marketing 11.15.18

Capsules | Supply Chain | Validation

Pharma Tech Industries

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Christopher Dale, Public Relations Director 11.14.18

QA/QC | Serialization | Supply Chain

Don’t Just Tick the Box, Think Outside Of It

How a quality-first approach to serialization can deliver long-term value beyond compliance.

Martin Van Trieste, CEO, Civica Rx and Board Member, rfxcel 11.13.18

Bio News | cGMP Manufacture | Facilities | Industry News | Inspections

GRAM Completes Successful FDA Inspection

Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued

11.09.18

Aseptic Processing | Formulation Development | Information Technology | Logistics | QA/QC

Galentic Pharma

Pranoy Parikh, Business Development 11.08.18

Validation

Pilgrim Quality Solutions, an IQVIA company

Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, Pilgrim has automated thousands of processes that ensur…

Sandy Carson, MarCom & Events Manager 11.08.18

Bio News | Industry News | Inspections

Avance Completes Successful FDA Inspection

Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.

10.31.18

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 industry

10.26.18