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Biologics, Proteins, Vaccines | Biosimilars
Biogenerics Progress
Generic makers target big forays into major marketsS. Harachand, Contributing Editor 06.12.18
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cGMP Manufacture
The Good, The Bad, and The Ugly Complexities of Pharmaceutical Manufacturing
What does it really take to develop, design, scale-up, commercialize and manage continuous processes?Girish Malhotra, Contributing Editor 06.12.18
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Analytical Services | Bioanalytical Services | Laboratory Testing
The Final Frontier
A look at contract bioprocessing and PAT/QbDEmil W. Ciurczak, DoraMaxx Consulting 06.12.18
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Information Technology
Putting Data Integrity in Quality Agreements
With growing regulatory scrutiny, sponsors are focusing more on data integrity in supplier quality agreements.Robert Marohn, ClinLogic, LLC 06.12.18
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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
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Decoding Company Culture: The Key to a Long Term Fit
Having shared and aligned values is critical to success in the workplace.Ryan Raver, PhD w/David G. Jensen 06.12.18
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The Salary Survey & Much More
From surveys, to drug development & delivery to compliance, the June issue covers a lot of ground06.12.18
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Regulatory Affairs
India raises bar for clinical trial oversight
New guidelines to bolster institutional ethical committeesS. Harachand, Contributing Editor 05.08.18
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Opportunities to Lower Drug Prices and Improve Affordability
From creation (manufacturing) to consumption (patient)Girish Malhotra, Contributing Editor 05.08.18
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Analytical Services | Laboratory Testing
We Need to Get Back to Basics
In life, and the lab, the calculator/computer is a blessing and a curse!Emil W. Ciurczak, DoraMaxx Consulting 05.08.18
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Regulatory Affairs
GDUFA II: Do You Have a Strategy?
Generic companies continue to face multiple challenges in an ever-increasing competitive market placeJanis A. Picurro, Lachman Consultants 05.08.18
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Core Traits to Take You the Distance
Six attributes recruiters and hiring managers look for in a candidate.David G. Jensen, Contributing Editor 05.08.18
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CMOs Growing Strong in APIs
Major API players in India continue to invest in operationsS Harachand, Contributing Editor 04.10.18
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Biologics, Proteins, Vaccines
Innovate UK Grant Supports Viral Vector Manufacturing
Cobra Biologics talks about its recently awarded $3.4 million capital infrastructure investmentBetsy Louda, Associate Editor 04.10.18
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Information Technology
New GXP Data Integrity Guidance Published by MHRA
New GXP Data Integrity Guidance Published by MHRARobert Marohn, ClinLogic, LLC 04.10.18
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Formulation Development
Some Changes in Formulation Paradigms
Old ways are slowly changing with the introduction of PAT and QbDEmil W. Ciurczak, DoraMaxx Consulting 04.10.18
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How Does Work Get Done In Pharma? By PEOPLE!
A high-octane primer on talent development for better business performanceBen Locwin, Contributing Editor 04.10.18
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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
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Leaving your Employer the ‘Right Way’
A look at the importance of finishing strong and going out on good termsRyan Raver and David G. Jensen, Contributing Editors 04.10.18
