Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

Due diligence is a requirement in any contractual dealings. In the specific context of pharmaceutical formulation and technology there are a number of different types of technical due diligence that can apply, viz:

Quality systems audit

Intellectual property assessment (e.g. does the patent art give sufficient exclusivity?)

Drug delivery technology assessment (e.g. will the proposed drug delivery technology be suitable for use with a particular API?)

Formulation assessment:

Potential drug development program in-license (e.g. is the formulation sufficiently developed to meet the project requirements and timelines?)

Potential drug product in-license (e.g. are the formulation and process sufficiently optimized and robust to meet expectations?)

To undertake any due diligence the assessor must have the appropriate knowledge, experience and understanding of the object of the assessment. For formulations this knowledge, experience and understanding will include all aspects of formulation from preformulation through to technical transfer and commercial validation. In addition an assessor is expected to understand the overall drug development process for any new drug candidate, and how formulation fits into the overall plan.

For drug development programs, the assessor will need to understand the different stages of the drug development and the differing requirements for both formulations and analytical methods as the overall development program progresses.

FinnBrit Consulting has the experience to advise clients on all the above aspects of due diligence issues.

All information published throughout www.finnbrit.com is intended for information only, and does not contain any warranties, implied or otherwise.

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