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Category Archives: FDA

Quality by Design: Essential, Not Optional

In today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool. In fact, the phrase, “essential instead of optional” reminds me of the…

Posted in API synthesis, APIs, Chemistry, CMC, FDA, Neuland Labs, outsourcing, QbD, Quality, regulatory | Comments Off on Quality by Design: Essential, Not Optional

APIs & Continuous Flow Manufacturing

Continuous drug manufacturing is reported to have begun with Novartis and MIT a decade ago, but no one would dare argue that it’s taken off like a rocket ship in…

Posted in API synthesis, CFM, Continuous flow manufacturing, continuous manufacturing, Contract Manufacturing, CRO/CMO, FDA | Comments Off on APIs & Continuous Flow Manufacturing

6 Pharma API Regulatory Challenges to Watch

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…

Posted in API synthesis, APIs, Big Data, FDA, genotoxic impurities, green chemistry, method development, Quality, regulatory, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Pharma API Regulatory Challenges to Watch

What are the Key Differences with Orphan Drug Manufacturing?

I was asked recently what a contract manufacturer such as Neuland Labs saw as the key differences with orphan drug projects. Neuland approaches orphan drug projects slightly differently from our…

Posted in deuterium exchange, drugs, FDA, Orphan drug | Comments Off on What are the Key Differences with Orphan Drug Manufacturing?

Quality Control & Assurance Are Constantly Evolving

Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…

Posted in Contract Manufacturing, FDA, Impurity profile, Neuland Labs, QA/QC, Quality | Comments Off on Quality Control & Assurance Are Constantly Evolving

APIs, Quality Agreements and the Partner-or-Supplier Debate.

It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.  The consensus seems to be that the FDA shifted the responsibility…

Posted in agreement, APIs, change orders, Contract Manufacturing, CRO/CMO, FDA, ICH, method development, Project Management, Quality Agreement | Comments Off on APIs, Quality Agreements and the Partner-or-Supplier Debate.

Are Current Genotoxic Impurity (GTI) Regulations Too Weak?

Genotoxic impurities were around long before humans first began boiling bark.  Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…

Posted in analytical science, Chemistry, CMC, Contract Manufacturing, FDA, genotoxic impurities, method development, Neuland Labs, regulatory | Comments Off on Are Current Genotoxic Impurity (GTI) Regulations Too Weak?

Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot. Thirty…

Posted in Capabilities, Chemistry, Contract Manufacturing, DMF, FDA, Neuland Labs, Project Management, R&D, regulatory, scale-up | Comments Off on Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

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