Navigation For Mobile
  1. >
  2. Blog
  3. >
  4. CRO/CMO
  5. >
  6. Page 2

Category Archives: CRO/CMO

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

Welcome, Unit 3!

Late last year, Neuland completed the acquisition of an API/Intermediate manufacturing facility in Hyderabad – now designated Unit III. The Unit III facility is spread across 12 acres and offers…

Posted in CDMO, Contract Manufacturing, CRO/CMO, Neuland Labs | Comments Off on Welcome, Unit 3!

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…

Posted in Contract Manufacturing, CRO/CMO, data, guarD, Neuland Labs, regulatory | Comments Off on Contract Pharma Project Management & Data Infrastructure

Pharma APIs – What’s On Tap for 2018

Gil Roth, president of the Pharma & Biopharma Outsourcing Association, recently published a piece at Contract Pharma on the challenges and opportunities facing CMOs/CDMOs. The hot button issues he described…

Posted in APIs, CDMO, Contract Manufacturing, ContractPharma.com, CRO/CMO, Neuland Labs | Comments Off on Pharma APIs – What’s On Tap for 2018

Synthetic Route Scouting: Factors to Improve API Manufacturing

Synthetic route selection is a crucial element in API manufacturing. While the requirements of the synthetic process of a drug will naturally evolve during its life cycle, scouting alternate routes…

Posted in API synthesis, APIs, atom economy, Benign-by-Design, Chemistry, Contract Manufacturing, CRO/CMO, green chemistry, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Synthetic Route Scouting: Factors to Improve API Manufacturing

Speed-to-Market: Streamlining Pharma API Production

In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor. How critical? A one-day delay in reaching the market could mean the loss of $1…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, Paragraph IV, process chemistry, Process Engineering, speed-to-market, time-to-market | Comments Off on Speed-to-Market: Streamlining Pharma API Production

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

5 Common Challenges Scaling Up an API

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Comments Off on 5 Common Challenges Scaling Up an API

5 Variables Shaping the Contract Pharma-Client Relationship

Several posts ago, I discussed an article on the ‘shifting sands’ of contract provider/pharma relationships, and how smart providers were responding to pharma’s needs, rather than establishing fixed models of…

Posted in analytical science, API synthesis, Chemistry, CMC, Contract Manufacturing, CRO/CMO, Neuland Labs | Comments Off on 5 Variables Shaping the Contract Pharma-Client Relationship

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