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Category Archives: Neuland Labs

Selecting Regulatory Starting Materials: A Q&A With Neuland’s Senior VP of Supply Chain Management

As a follow-up to our recent two-part series on Regulatory Starting Materials Sourcing & Supplier Management, we sat down with Senior Vice President of Supply Chain Management at Neuland Labs…

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Real-Time Remote GMP Inspections by Key Regulatory Agencies

We’ve arrived at a time in which real-time remote GMP inspections of drug manufacturing facilities are an actual thing – and not just an “it would be nice to have…

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Exploring Neuland’s Therapeutic Segments: Focus on CNS

Drug development is exciting. There’s no getting around it: being a part of an industry which aims to improve human health is a great motivator for waking up and heading…

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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….

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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…

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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…

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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