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 ...

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 Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...

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 ...

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...

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 ...

BOSTON, Dec.16, 2025 – Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, and Quotient Sciences, a leading global clinical development and ...

A pair of recently-released studies shed new light on the staggering cost of developing new drugs—an expense that now exceeds $2 billion per therapy on average. In one report, business services ...

US Food and Drug Administration, Silver Spring, MD, USA. Amyotrophic lateral sclerosis (ALS) is a severe progressive, neurodegenerative disease. It is also rare, and has been the focus of substantial ...

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 ...

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 ...