STRATEGIC DEVELOPMENT ADVICE

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. During development, our clients face many challenges. The Pharmexon team is able to perform ongoing due diligence, as well as offer on-site support (if required) in order to assist in continued successful development. Additionally, we are able to advise and support the appropriate strategy to begin and/or continue dialogue with Agency experts as part of a Scientific Advice program. Our experts are able to review a development from the perspective of regulators, and the wider network is able to provide inputs into practical elements of a development. Additionally, our team can provide advice on leveraging data being generated for a specific region and how a program can be truncated for another region.

Example of services:

• Due Diligence of CMC data during formulation development and scale-up
• Synopsis/protocol and reports of preclinical and clinical program
• Ongoing support of development processes
• Analytical methods, raw material qualification, process controls
• Review of preclinical programs
• Preparation and review of PK data for standard/complex generics
• Scientific Advise full service: 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 different worldwide regulatory regions
• Quality development program (i.e. Sameness studies, comparability, batch selection, QTPP, QbD, etc)

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