PRE-DEVELOPMENT

Pharmexon is able to advise on aspects of the development of a medicinal product or device at any stage of development. More notably, our clients would like “strategic inputs” even at target selection stage. This is important to note in order to understand the local and global pathway a development must follow. We are able to apply our experiences to identify possible pitfalls and common problem that can occur. Our experts are able to design preclinical and clinical strategies, synopsis and protocol. We provide appraisals of data/ideas as well as set-up and facilitate interaction with Agency committees.

Some of the services offered in this area are:

• Due Diligence of CMC data during formulation development and scale-up
• Due Diligence of Synopsis/protocol and reports of preclinical and clinical program
• Ongoing support of development processes, analytical methods,raw material qualification, process controls
• Review of preclinical data in order to present clinical program to regulators
• Preparation and review of PK data for standard/complex generics
• Preparation of Briefing Books including Question placement, data presentation, face-to-face representation and extrapolation of outcomes
• On-site support and monitoring of clinical/nonclinical studies
• Clinical trial applications - preparation and support
• Critical support, reviews and data use between EU and US

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