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

Category Archives: Quality

Generic Drugs: Despite Dominance, Consumer Perception Issues Linger

Generics: U.S. Drug Industry Dominance The last time you filled a prescription, was it a generic or a brand name drug? An astonishing 89% of all drug prescriptions in the…

Posted in APIs, drugs, generic, Neuland Labs, Quality, regulatory, supply chain | Comments Off on Generic Drugs: Despite Dominance, Consumer Perception Issues Linger

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

Inside QBD: Chemists & Engineers Collaborate on Quality

In a PharmTech webcast, the Neuland team linked up with Dr. San Kiang – Research Professor from the Department of Chemical Engineering at Rutgers University. The objective was a discussion…

Posted in Chemistry, drug discovery, drugs, process chemistry, Process Engineering, QbD, Quality, R&D, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Inside QBD: Chemists & Engineers Collaborate on Quality

Neuland & Regulatory Excellence

With more than 650 regulatory filings to date, Neuland is committed to total compliance and regulatory excellence. In fact, we consider it our core competency: the application of strong process…

Posted in APIs, audit, award, Capabilities, CDMO, Contract Manufacturing, FDA, Neuland Labs, QA/QC, Quality, Quality Agreement, regulatory, Uncategorized | Comments Off on Neuland & Regulatory Excellence

3 Success Factors for Pharma Regulatory Inspections

Current Good Manufacturing Practices (cGMPs) are an essential aspect of compliance, and attention on them by regulators is growing. In today’s global pharma industry, it’s common to have multiple investigators…

Posted in APIs, audit, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, FDA, Neuland Labs, QA/QC, Quality, regulatory | Comments Off on 3 Success Factors for Pharma Regulatory Inspections

Leveraging QbD for API Scale Up

Earlier this month we wrote a piece on the Five Challenges Scaling Up an Active Pharmaceutical Ingredient (API). In the post’s conclusion, we discussed the role of QbD in aiding…

Posted in API synthesis, APIs, Design of Experiment, method development, Neuland Labs, QbD, Quality, regulatory, Uncategorized | Comments Off on Leveraging QbD for API Scale Up

Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Neuland has recently welcomed the addition of a new, dedicated Process Engineering Lab to its R&D Center. The lab opened in March, and supports operations and safety studies via a…

Posted in Chemistry, CMC, Contract Manufacturing, drugs, method development, Neuland Labs, process chemistry, Process Engineering, QbD, Quality, Quality Agreement, R&D, Route Design, scale-up, synthesis | Comments Off on Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Defining the Relationship Between the Pharma Industry & Regulatory Agencies

I read an article at PharmTech at the tail end of 2016 that I thought was quite interesting, and it reflects Neuland’s position on regulatory agencies & issues. The article…

Posted in Contract Manufacturing, CRO/CMO, drugs, FDA, Neuland Labs, Pharm Tech, Pharmaceutical Technology, Quality, regulatory | Comments Off on Defining the Relationship Between the Pharma Industry & Regulatory Agencies

In Pharma, Quality is Everything. All Else is Secondary.

We are firm believers that quality is more important than…well…everything in the pharma business. It’s very simple: in this highly-regulated industry, without quality – a company has no value. We…

Posted in Neuland Labs, QA/QC, Quality | Comments Off on In Pharma, Quality is Everything. All Else is Secondary.

The Outsized Impact of Smaller Pharma CDMOs

One portion of an article at PharmTech (Five Themes That Will Drive the CMO Industry) discussing opportunities for smaller CMOs recently caught my eye. It mentioned that those aforementioned opportunities…

Posted in Capabilities, CDMO, Contract Manufacturing, CRO/CMO, Neuland Labs, outsourcing, process chemistry, QA/QC, Quality, R&D, regulatory, scale-up | Comments Off on The Outsized Impact of Smaller Pharma CDMOs