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By Emil W. Ciurczak, DoraMaxx Consulting
Published January 29, 2015
A new generation of equipment will help generate products with less cost and effort, while being made more efficiently Read More »
Heavy Metals in Drug Products
By Nikki Schopp, Team Leader in charge of ICP-MS, ICP-OES and AA testing, SGS
Published January 29, 2015
The potential presence of trace amounts of heavy metals in drug products is a real cause for concern with regulators such as FDA and EMA Read More »
Jump Starting the Non-Profit Research Engine
By Kate Hilyard , Managing Director, BioFocus
Published January 29, 2015
How CROs are teaming up with disease foundations to accelerate drug discovery Read More »
Supplier Selection A Roadmap to a Good Start
By George Tyson, CMC and supply chain consultant
Published January 29, 2015
Good supplier selection is a key element of success in the pharmaceutical industry today Read More »
Published January 28, 2015
2015 PDA Annual Meeting includes a track dedicated to manufacturing performance. Read More »
Published January 20, 2015
Adds 50% to clinical trial packaging, storage and distribution capacity Read More »
Published January 14, 2015
Gains exclusive rights to oncology target Read More »
Published January 14, 2015
Validates MSD V-PLEX 10-plex Proinflammatory Panel Read More »
Published January 9, 2015
Aims to identify new treatment approaches for diseases with significant unmet need Read More »
Published January 5, 2015
Aims to develop and commercialize next-gen (CAR) T cell immunotherapies Read More »
Published December 19, 2014
In order to maintain high product quality and productivity, setting high standards of cleanliness is critical. Through extensive research and the collaboration of leading pharmaceutical and personal care companies, Gamajet has created customer-driven… Read More »
Published December 9, 2014
Wuchterl to oversee R&D services, manufacturing, engineering, and program management Read More »
Published December 2, 2014
Will double lab size to accommodate increasing FTE activities and stability projects Read More »
Syenz Pharmaceutical Research & Development
Published November 24, 2014
Contract Laboratory Services Read More »
Published November 19, 2014
Implements Version V3.1.6 at its largest manufacturing facility Read More »
Published November 18, 2014
System ensures room isolation during fluid transfer Read More »
By S. Harachand, Contributing Editor
Published November 13, 2014
India raises the bar in production quality. Read More »
The New EU GMPs for Cross Contamination
By Stephanie Wilkins , PharmaConsult US, Inc.
Published November 13, 2014
Industry needs to prepare in order to comply with the updates. Read More »
Next-Gen ADCs: Collaborating to Improve Supply Chains for Development and Technology
By Dr. Cynthia Wooge and Dr. Jyothi Swamy , SAFC
Published November 13, 2014
A look into today’s ADC landscape and how collaboration aims to address ADC customer challenges. Read More »
Clinical Trial Supplies 101: Outsourcing Primer for Virtual Pharma and Biopharma Companies, Part II
By Alex McClung, Xcelience
Published November 13, 2014
Getting packaged investigational materials dispensed to the patients taking part in clinical trials, on time and correctly, requires orchestrating myriad activities. This is the second in a series of articles outlining specific quality concerns associated with packaging clinical trial supplies and how to effectively manage those concerns. Read More »
Published November 12, 2014
Now able to extend offerings in the U.S. from contract development to manufacturing. Read More »
Published November 4, 2014
New analytical lab will focus on analytical quality control testing Read More »
Published October 28, 2014
Gains exclusive option to acquire F-star Alpha and lead anti-cancer asset Read More »
Agile Drug Development: Lessons from the Software Industry
By Pedram Alaedini, Birnur Ozbas PhD, and Fahri Akdemir, Primapax and C1 Consulting
Published October 14, 2014
Why pharma needs to move from a “waterfall” to a “scrum” model Read More »
Contract Pharma’s 15th Anniversary Retrospective: Then & Now
By Kristin Brooks, Contract Pharma
Published October 14, 2014
A look back at the pharma/biopharma industry and outsourcing. Read More »
Assuring Quality from CMO’s
By Dr. Kevin Siver, PhD, Onyx Pharmaceuticals
Published October 1, 2014
Serving Patients is a Privilege. This Privilege Comes with Significant Responsibilities Read More »
Published October 1, 2014
Complies with excipient 
GMPs Read More »
Published September 30, 2014
Transitions molecule into preclinical development for the treatment of endometriosis Read More »
Published September 25, 2014
Will align conjugation and manufacture of drug linkers with sterile fill/finish services Read More »
Published September 22, 2014
Expands growth platforms for Lab & Academia business pharma and biopharma production Read More »
Published September 16, 2014
Adds serialization for labeling and encoding, updates ops Read More »
Published September 12, 2014
Will leverage Evotec's high-throughput screening and proteomics platforms Read More »
Staying Ahead of Regulatory Change
By Dan Pearce, Catalent Pharma Solutions
Published September 8, 2014
A rigorous system of regulatory intelligence and analysis is needed to manage changes, trends and observations in a global QMS Read More »
By Emil W. Ciurczak, DoraMaxx Consulting
Published September 8, 2014
This is the first part in a series of articles discussing how process analytical technology (PAT) can add to your bottom line and suggesting baby steps you can take to using it. Read More »
Outsourcing Media and Buffer Prep
By Eric S. Langer, BioPlan Associates, Inc.
Published September 8, 2014
Facilities are evaluating ways to reduce bottlenecks, lower risks, eliminate logistics and inventory costs Read More »
Strange Ally in the War Against Sepsis
By Agnes Shanley , Editor
Published September 8, 2014
50 years ago this year, scientists first connected an ancient sea creature to testing for life-threatening bacteria Read More »
Be Proactive About Disinfection Qualification
By Dave Rottjakob, Deborah Ensign, Shawn Sherry, and Kate Bloomrose
Published September 8, 2014
Unfortunately, most manufacturers wait until after a 483 or performance problem to revisit qualification practices. Proactive testing and continued monitoring ensure patient safety and compliance Read More »
The Audit Trail Advantage
By Carol Brandt , GMP Compliance Consulting, NNE Pharmaplan
Published September 8, 2014
Why one of FDA’s most misunderstood rules can help ensure data integrity and compliance, and help in root cause analysis Read More »
Risk and Quality Management: Connecting the Dots
By Bikash Chatterjee , President and CTO, Pharmatech
Published September 8, 2014
A brief review of pharma’s new thinking regarding quality and risk management, and key risk management tools Read More »
Published September 3, 2014
CMC to provide development, clinical manufacture of antibody candidate Read More »
Published August 22, 2014
Flow cytometry is a laser-based technology that analyzes multiple characteristics of a single particle (usually cells). Read More »
Published July 22, 2014
Williams and Schultz take on VP roles Read More »
Published July 22, 2014
Will produce NME for U.S. market Read More »
Published July 3, 2014
To establish library of more than 200,000 compounds Read More »
Published June 13, 2014
Validation study shows 50% reduction in QC time Read More »
Published June 5, 2014
Aims to speed drug development Read More »
What You Need to Know About QbR
By Emil W. Ciurczak , DoraMaxx Consulting
Published June 3, 2014
FDA’s Question-Based Review requires more information in key areas Read More »
Improving the Functional Characterization of Biosimilars
By Delana Butz, Ph.D., Manuela Grassi, Ph.D, Onesmo Mpanju, Ph.D., Duu-Gong Wu, Ph.D., Peter Wunderli, Ph.D. , PPD
Published June 3, 2014
New bioassay methods may help reduce the variability of analytical methods required to demonstrate comparability Read More »
Biopharma CMO Update
By William Downey , HighTech Business Decisions
Published June 3, 2014
Increased demand is driving higher capacity utilization and more partnerships Read More »


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