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Category Archives: Neuland Labs

How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…

Posted in APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, scale-up | Tagged , , , , | Comments Off on How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

API Production: Building a Process Safety Culture

Working in the pharmaceutical manufacturing industry may bring many rewards, but it also has an element of risk. We often work alongside hazardous chemicals, in both labs and manufacturing spaces….

Posted in API synthesis, APIs, Capabilities, Chemistry, EHS, Neuland Labs, process chemistry, Process Engineering, safety | Tagged , , , | Comments Off on API Production: Building a Process Safety Culture

Overcoming the Challenges of API Complexity

Pharmaceutical drug molecules are becoming increasingly complex, posing challenges in formulation development and manufacturing. This is particularly true of small molecule drug APIs and peptides, both of which have a…

Posted in API synthesis, APIs, atom economy, Chemistry, corporate stewardship, drugs, Effluent, EHS, energy conservation, energy effciency, green chemistry, Neuland Labs | Tagged , , , , | Comments Off on Overcoming the Challenges of API Complexity

Weighing the Potential for APIs and Finished Dosage Forms in Emerging Markets

New markets for drug manufacturers are emerging worldwide in regions that have typically purchased and imported drugs in finished dosage forms. While this shift has been underway for a few…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, drugs, generic, Neuland Labs, supply chain | Tagged , , , , , | Comments Off on Weighing the Potential for APIs and Finished Dosage Forms in Emerging Markets

Economic Nationalism or Global Cooperation? How About a “Thank You,” Instead?

I saw this lede for an article (Bio/Pharma, People, Perseverance, and Hope) about 2020 by Rita Peters at PharmTech and smiled. It captured the state of life sciences this past…

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Improving Investigations: An Inspector’s Perspective

Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…

Posted in audit, CMC, COVID19, FDA, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , , , , | Comments Off on Improving Investigations: An Inspector’s Perspective

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Have other areas in drug discovery suffered because of COVID-19? It’s probably not too early to say that COVID-19 has changed pharmaceutical drug discovery considerably. And why wouldn’t it have,…

Posted in Chemistry, drug discovery, drugs, FDA, Neuland Labs, R&D, regulatory | Tagged , , | Comments Off on Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Pharma Manufacturing Operations in the Time of COVID-19

There has been a flood of articles recently on how companies have adapted to our new reality in a coronavirus-affected world. As an essential services manufacturer and lab, Neuland has…

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