Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

The biotechnology and pharmaceutical industries must adapt to new advancements to develop new therapies for patients with unmet needs. In this exciting time, there are a range of advanced modalities ...

Learn how FTIR spectroscopy simplifies pharmaceutical formulation by providing rapid, accurate molecular analysis.

Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique ...

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data ...

QbD is an industry initiative supported by regulators. However, it is also a systematic method of process development which delivers consistency, robustness and increased process knowledge. This ...

Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

Compounded pharmaceutical dosage forms may be generally described as preparations that are not commercially available from major pharma corporations. These preparations have traditionally been ...