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 ...

Many challenges face developers of drugs for rare diseases, including the small number of patients available for clinical trials, genotypic and phenotypic diversity within a disorder, poorly ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

WHIPPANY, N.J.--(BUSINESS WIRE)--Halo Pharma, a rapidly growing contract development and manufacturing organization (CDMO), offers more than 30 years’ direct experience in the production of topical ...

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...

Domestic manufacturing can improve quality oversight by reducing foreign inspection gaps and enabling early FDA engagement ...

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 ...

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 ...

BioSelective Capital Investments and Shayan Enterprises, LLC, a Utah-based risk-capital investment firm, today announced the successful acquisition of BioDuro’s drug product development and ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

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 ...