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FDA’s New Draft Guidance on Container Closure Systems: What Drug Developers Need to Know A risk-based approach puts packaging suitability, compatibility and performance firmly within the broader CMC strategy For nearly three decades, the FDA’s approach to container closure systems (CCSs) for human drugs and biological products has bee...
From diabetes management to obesity, cardiovascular risk and emerging metabolic indications, GLP-1 therapies are changing what sponsors expect from clinical development. The next challenge is not simply developing another GLP-1. It is designing and executing the right study, in the right patients, with the right evidence. The GLP-1 revolution has m...
What pharmaceutical companies in India need to know about Schedule M, inspection readiness and building an effective pharmacovigilance system On 3 June 2026, CDSCO issued a circular on the implementation of the Pharmacovigilance (PV) System under Schedule M of the Drugs & Cosmetics Act, 1940 and the Rules made thereunder. The circular specifica...
The U.S. biopharmaceutical industry is entering a new phase of innovation, one shaped by increasing R&D costs, impending patent expirations and the growing need to strengthen development pipelines through external innovation. As a result, cross-border licensing has become an important strategy for biopharma companies seeking to accelerate drug ...
Five Mistakes Companies Make During eCTD 4.0 Implementation And How to Avoid Them The regulatory landscape is entering one of its most significant periods of transformation since the adoption of electronic submissions. As health authorities worldwide prepare for eCTD 4.0 implementation, pharmaceutical, biotechnology and medical device companies fac...
How biotech companies can identify the right CRO partner to accelerate patient recruitment, improve trial quality, reduce operational burden and deliver regulatory-ready data. The way clinical trials are conducted has changed dramatically over the last five years. What began as a necessity during the COVID-19 pandemic has evolved into a strategic a...
Pharmaceutical organizations are facing a new challenge that goes beyond clinical development, pharmacovigilance and regulatory submissions: controlling who can access sensitive data, where they can access it from and how every access decision is documented. Regulatory changes, strengthened national security requirements and increasingly complex cr...
Bringing a new therapy to market is one of the most significant milestones in a pharmaceutical or biotechnology company's journey. Yet, while organizations invest substantial resources in clinical development, regulatory submissions and commercialization planning, many underestimate the complexity of building a compliant and scalable pharmacovigila...
Biotech and pharma companies face increasing pressure to accelerate timelines, manage costs, cater to regulatory changes and maintain quality across global programs. As clinical trials become more complex, selecting the right outsourcing model has become a strategic decision rather than simply an operational one. Among the most widely adopted appro...
Scientific breakthroughs in oncology, rare diseases, cell and gene therapies, immunology and precision medicine are increasingly being driven by agile and innovative biotech companies rather than pharmaceutical giants alone. Yet many emerging organizations face a familiar challenge: how can they achieve the operational sophistication of large pharm...