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Yearly Archives: 2014

Generic Drugs – The Freedom to Operate

In a recent post about contract manufacturing and IP, I discussed how Neuland doesn’t compete with clients in the generics space. A friend in Pharma subsequently asked me my thoughts…

Posted in Contract Manufacturing, Freedom to Operate, IP, Patent | Comments Off on Generic Drugs – The Freedom to Operate

“Is Your Team Skilled at Technical Writing?” – Why CRO/CMOs Should Hone Their Skills

As an advanced chemistry solutions provider, we are constantly asked by jobseekers which particular skills we are looking for in job candidates. Knowledge of complex chemistry? Demonstrable scientific problem-solving skills?…

Posted in Contract Manufacturing, CRO/CMO, technical writing | Comments Off on “Is Your Team Skilled at Technical Writing?” – Why CRO/CMOs Should Hone Their Skills

The New Look of Neuland

You may have noticed we have a new style! Neuland recently unveiled our exciting new branding. It’s a refresh of Neuland’s look and a reminder of the values we cherish as…

Posted in marketing, Neuland Labs | Comments Off on The New Look of Neuland

API Micronization & Nanosizing: Mastering Particle Size

Micronizing – and particularly nanosizing – active pharmaceutical ingredients (APIs) has become an integral part of the drug development & manufacturing process. And with a variety of techniques available to…

Posted in APIs, Chemistry, CMC, drug delivery, R&D, scale-up | Comments Off on API Micronization & Nanosizing: Mastering Particle Size

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

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.

Genotoxic Impurities – Article in PharmTech

Related to our (persistent!) emphasis on regulatory excellence and complex chemistry capabilities, team members from Neuland Lab’s Analytical Research & Development Department at our R&D Centre developed and validated a…

Posted in Chemistry, genotoxic impurities, Pharmaceutical Technology, R&D, regulatory | Comments Off on Genotoxic Impurities – Article in PharmTech

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

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?

FDA Commissioner Acknowledges Good Indian Firms

In February, FDA Commissioner Hamburg became the first-ever U.S. FDA commissioner to make an official visit to India. In a blog post back on February 11th – prior to her…

Posted in FDA, regulatory | Comments Off on FDA Commissioner Acknowledges Good Indian Firms

Fine-Tuning the Reaction: Pharma Embraces Contract Chemistry

Bromination? Diazotization? Oxidation? Methylation? Niche chemistry is critical to the success of most therapeutics – whether it’s a cardiovascular, anti-fungal, anti-emetic, CNS, Parkinson’s or other drug. Pharmaceutical companies continue to…

Posted in Chemistry, CMC, Contract Manufacturing, CRO/CMO, Project Management, Uncategorized | Comments Off on Fine-Tuning the Reaction: Pharma Embraces Contract Chemistry

API Regulatory Challenges: 5 Things You Need to Avoid

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