Pharmaceutical Technology-08-01-2015

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.

What if the expanding pipeline isn’t enough to fuel CMO growth?

Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.