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Yearly Archives: 2013

FDA Quality Audits: What You (and Your CMO) Should Be Doing

Many companies dread FDA quality audits…even when they’ve invested the preparation, long-term vigilance and dedication to quality to make them a success. The growing number of pharma and biotech firms…

Posted in Contract Manufacturing, CRO/CMO, FDA, QA/QC, regulatory | Comments Off on FDA Quality Audits: What You (and Your CMO) Should Be Doing

Peptide Synthesis: Solution Phase, Solid Phase or Hybrid?

Choosing the Right Synthesis Technique for Your Peptide API. Peptide synthesis has roots dating back more than a century. Given its age, it may seem strange that peptide synthesis is…

Posted in Uncategorized | Comments Off on Peptide Synthesis: Solution Phase, Solid Phase or Hybrid?

Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

We’re so excited! Neuland Labs just received a huge award – the 2013 CMO Leadership Award in the Regulatory category from Life Science Leader magazine. It’s an honor to have…

Posted in APIs, award, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

With research becoming highly-specialized, many companies are turning to CROs with particular skill-sets – especially in complex chemistry. For us at Neuland, companies tend to be looking for method development…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, genotoxic impurities | Comments Off on Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

Made in India: The Outlook for Pharma’s Manufacturing Hub

I’ve written before about the incredible speed of the Pharma industry’s growth in India, and the future outlook continues to look very bright. While the Indian pharma market is facing…

Posted in Contract Manufacturing, CRO/CMO, DMF, FDA, regulatory, scale-up | Comments Off on Made in India: The Outlook for Pharma’s Manufacturing Hub

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

Contracting Abroad: FDA-Approved Capacity, Faster Clinical Trial Enrollment and Lower Cost

There’s no doubt: India is a pharmaceutical powerhouse when it comes to global outsourcing. Its pharma and biopharma customers are as diverse as the range of services and benefits available…

Posted in Uncategorized | Comments Off on Contracting Abroad: FDA-Approved Capacity, Faster Clinical Trial Enrollment and Lower Cost

Overcoming Scale-up Issues: When Your CRO Becomes Your CMO

The transition from discovery and research to full manufacturing marks a critical time in a drug candidate’s lifecycle. Whether a company completes the scale-up process entirely in-house, with a single…

Posted in APIs, Contract Manufacturing, CRO/CMO, scale-up | Comments Off on Overcoming Scale-up Issues: When Your CRO Becomes Your CMO

Upcoming Webinar: Risk Mitigation for API Manufacturing

Join us Wednesday, June 19, 2013 from 11:00 am–12:00 pm EDT for a free webcast that will provide insight and case-study analysis on the approaches taken by pharmaceutical companies to build…

Posted in APIs, Contract Manufacturing, upcoming events, webinar | Comments Off on Upcoming Webinar: Risk Mitigation for API Manufacturing

What Services Do Pharmaceutical Companies Look for in a Manufacturing Partner?

Outsourcing to a contract manufacturer these days means more than just having your product manufactured and drop-shipped. But what – exactly – are today’s pharma companies expecting from their manufacturing…

Posted in Contract Manufacturing, CRO/CMO, FDA, regulatory | Comments Off on What Services Do Pharmaceutical Companies Look for in a Manufacturing Partner?