Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different. The many ways the ...

AI and machine learning are revolutionizing drug discovery, development, and lifecycle management, addressing industry ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

The process of drug development can lengthy and complex, with multiple stages and regulatory requirements to be met. In the United States, the Food and Drug Administration (FDA) is responsible for ...

Oxana Iliach is a Senior Director of Regulatory Strategy at Certara (PA, USA), a biotech company that offers comprehensive solutions for transforming and accelerating drug development. In her spare ...

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

MISSISSAUGA, Canada--(BUSINESS WIRE)--Eurofins CDMO Alphora Inc., a global Contract Development & Manufacturing Organization and part of the international network of Eurofins laboratories, is pleased ...

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial manufacture of drug products.