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Category Archives: regulatory

Drug API & Peptide Trends: 2019

With the global population continuing to both increase and age, pharma industry growth is likely to continue. While facing pricing hurdles in well-established mature markets, the emerging drug markets (China,…

Posted in API synthesis, APIs, CDMO, Contract Manufacturing, CRO/CMO, generic, Neuland Labs, peptide, peptides, process chemistry, Process Engineering, QA/QC, QbD, regulatory, Route Design, Route Scouting | Comments Off on Drug API & Peptide Trends: 2019

Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

Drug product volumes have been shrinking as increasingly niche products emerge to treat various conditions. Coupled with the rise of pharmaceutical manufacturing outsourcing, this has led to a reconsideration of…

Posted in APIs, Chemistry, Contract Manufacturing, cytotoxic, drugs, FDA, Neuland Labs, oncology, regulatory, Schedule M | Tagged , , , , | Comments Off on Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

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…

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Contract Pharma Project Management & Data Infrastructure

For pharma manufacturers, developing rock-solid data infrastructure has become essential. It touches everything we do as a CDMO – from the web-based intranet used for Employee Self Service (ESS), Sales…

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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

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

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

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