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Category Archives: QA/QC

The Contract Manufacturing & Intellectual Property Challenge: Solution? Don’t Compete With the Customer.

Posted on May 4, 2014 by

Intellectual property rights have always been integral to negotiations for pharmaceutical contract manufacturing services, but growing complexities surrounding global IP issues, complex science, inevitable process improvements, IT infrastructure & security,…

Posted in agreement, APIs, Contract Manufacturing, CRO/CMO, genotoxic impurities, QA/QC, Uncategorized | Comments Off on The Contract Manufacturing & Intellectual Property Challenge: Solution? Don’t Compete With the Customer.

Are Cost Savings Still Driving the Surge in Life Sciences Contract Services?

Posted on March 31, 2014 by

Highly-Specialized Expertise Helps Pharma Focus on What They Do Best The discovery, manufacture and marketing of drugs is complex business indeed. So complex, in fact, that even the biggest of…

Posted in Chemistry, Contract Manufacturing, CRO/CMO, FDA, QA/QC, regulatory | Comments Off on Are Cost Savings Still Driving the Surge in Life Sciences Contract Services?

API Regulatory Challenges: 5 Things You Need to Avoid

Posted on January 10, 2014 by

At the heart of every drug lies one or more active pharmaceutical ingredients (APIs). While the phrase “regulatory affairs” typically conjures thoughts of FDA approvals of finished-dose drugs, regulatory matters…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on API Regulatory Challenges: 5 Things You Need to Avoid

FDA Quality Audits: What You (and Your CMO) Should Be Doing

Posted on December 3, 2013 by

Many companies dread FDA quality audits…even when they’ve invested the preparation, long-term vigilance and dedication to quality to make them a success. The growing number of pharma and biotech firms…

Posted in Contract Manufacturing, CRO/CMO, FDA, QA/QC, regulatory | Comments Off on FDA Quality Audits: What You (and Your CMO) Should Be Doing

Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

Posted on October 18, 2013 by

We’re so excited! Neuland Labs just received a huge award – the 2013 CMO Leadership Award in the Regulatory category from Life Science Leader magazine. It’s an honor to have…

Posted in APIs, award, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Posted on April 1, 2013 by

For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…

Posted in CEP, Congtract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Looking for an API Supplier? 5 Things to Consider

Posted on March 6, 2013 by

Outsourcing production of APIs provides pharmaceutical and biotech companies the benefit of API scale-up and production expertise while allowing them to focus on their core business – the research and…

Posted in APIs, Contract Manufacturing, CRO/CMO, QA/QC, regulatory | Comments Off on Looking for an API Supplier? 5 Things to Consider