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Category Archives: Project Management

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)

Defining the Contract Pharma Provider Relationship

I read an article at Pharmaceutical Manufacturing earlier this year (Inking the Deal: Mastering the art of lasting outsourcing relationships in the pharmaceutical industry) on the nature of contract pharma…

Posted in agreement, APIs, Contract Manufacturing, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Project Management | Comments Off on Defining the Contract Pharma Provider Relationship

How Process Engineering Techniques Result in Cost-Effective Products

With the cost pressures of today’s competitive market, active pharma ingredient (API) sales profit margins are continuously falling. As a result, pharmaceutical manufacturers find themselves under pressure to cut production…

Posted in Chemistry, Contract Manufacturing, method development, Neuland Labs, PAT, process chemistry, Process Engineering, Project Management | Comments Off on How Process Engineering Techniques Result in Cost-Effective Products

Successful Pharma Partnering: Managing the CMO Relationship

With everything involved in bringing a drug to market, enlisting the services of an experienced CMO can prove to be a very worthy investment. Ideally, the relationship between a pharma…

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APIs, Quality Agreements and the Partner-or-Supplier Debate.

It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.  The consensus seems to be that the FDA shifted the responsibility…

Posted in agreement, APIs, change orders, Contract Manufacturing, CRO/CMO, FDA, ICH, method development, Project Management, Quality Agreement | Comments Off on APIs, Quality Agreements and the Partner-or-Supplier Debate.

Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot. Thirty…

Posted in Capabilities, Chemistry, Contract Manufacturing, DMF, FDA, Neuland Labs, Project Management, R&D, regulatory, scale-up | Comments Off on Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

Fine-Tuning the Reaction: Pharma Embraces Contract Chemistry

Bromination? Diazotization? Oxidation? Methylation? Niche chemistry is critical to the success of most therapeutics – whether it’s a cardiovascular, anti-fungal, anti-emetic, CNS, Parkinson’s or other drug. Pharmaceutical companies continue to…

Posted in Chemistry, CMC, Contract Manufacturing, CRO/CMO, Project Management, Uncategorized | Comments Off on Fine-Tuning the Reaction: Pharma Embraces Contract Chemistry

Integrating Your Contract Manufacturer Into Your Supply Chain: Your API is a Web Browser Click Away

Life Sciences Supply Chain Management – The Stakes Are High. Supply chain management is top of mind these days…and with good reason: your company’s bottom line is at stake. Nowhere…

Posted in APIs, CCPM, Contract Manufacturing, CRO/CMO, guarD, Project Management, Uncategorized | Comments Off on Integrating Your Contract Manufacturer Into Your Supply Chain: Your API is a Web Browser Click Away