Navigation For Mobile
  1. >
  2. Blog
  3. >
  4. regulatory
  5. >
  6. Page 4

Category Archives: regulatory

Investigation of Various Impurities in Febuxostat

In this month’s issue of PharmTech, team members at Neuland’s R&D Center in Hyderabad published a peer-reviewed article on the analysis and management of impurities in the drug Febuxostat. Febuxostat, a…

Posted in analytical science, Capabilities, Chemistry, drugs, Febuxostat, method development, Neuland Labs, peer-review, Pharm Tech, Pharmaceutical Technology, QA/QC, regulatory | Comments Off on Investigation of Various Impurities in Febuxostat

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

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

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

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

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

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

Made in India: The Outlook for Pharma’s Manufacturing Hub

I’ve written before about the incredible speed of the Pharma industry’s growth in India, and the future outlook continues to look very bright. While the Indian pharma market is facing…

Posted in Contract Manufacturing, CRO/CMO, DMF, FDA, regulatory, scale-up | Comments Off on Made in India: The Outlook for Pharma’s Manufacturing Hub

What Services Do Pharmaceutical Companies Look for in a Manufacturing Partner?

Outsourcing to a contract manufacturer these days means more than just having your product manufactured and drop-shipped. But what – exactly – are today’s pharma companies expecting from their manufacturing…

Posted in Contract Manufacturing, CRO/CMO, FDA, regulatory | Comments Off on What Services Do Pharmaceutical Companies Look for in a Manufacturing Partner?