We author publications presenting our opinions, methodological approaches to health
products development, and our views on environment changes.

Regulatory approval and market access: a winning combination for drug launch optimization

SCRIP Regulatory Affairs

Having a combined regulatory and market access strategy is critical for a drug launch to be successful.

Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives

Orphanet Journal of Rare Diseases

There is growing recognition that the current research-and-development (R&D) and innovation-regulation ecosystem could be made more efficient to stimulate and support access to innovative therapies for those patients with rare, life-threatening diseases for which there are no adequate licensed therapies.

Clinical Trials in the EU/EEA- Focus on CMC Aspects

Pharmaceutical Outsourcing

Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC [1]. This has led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each concerned MS.

Current Clinical Trial Scenario of India

Pharma Bio World

The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil today with a decline of 9.60 per cent in revenues, with further decline because of delay/decreased clinical trial approvals.

The proposed EU IVD Regulation and its impact on companion diagnostic development

SCRIP Regulatory Affairs

Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.

Designing a CMC strategy for advanced therapy medicinal products in EU

SCRIP Regulatory Affairs

Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.