Viewpoints

Aug 02, 2018
Pharmaceutical Technology
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jun 02, 2018
Pharmaceutical Technology
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
Jun 02, 2018
Pharmaceutical Technology
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
May 02, 2018
Pharmaceutical Technology
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Mar 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
Mar 02, 2018
Pharmaceutical Technology
FDA enforcement efforts and drug approvals trend upward.
Feb 02, 2018
Pharmaceutical Technology
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
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