IMPD – Quality writing and review
–Writing and reviewing the Quality section of the IMPD
Having worked extensively within the Regulatory CMC area, I am capable and qualified in writing and reviewing the quality section of the Investigational Medicinal Product Dossier (IMPD) – one of the three essential scientific documents required by authorities for Clinical Trial Authorisation. The quality section contains information on the Chemistry, Manufacture & Control of the drug substance and drug product.
The requirements for the content and documentation included in the IMPD increases during the development process and I can provide expert advice and hands-on experience in this complex area throughout clinical development.
–CMC coordination with Contract Manufacturing Organisations
Chemistry, Manufacture & Control of the drug candidate – ”CMC” is one of the three pilars in pharmaceutical development. Whereas non-clinical and clinical have a defined and limited period of relevans, the CMC area is continuesly developed throughout the development and life-cycle of the drug substance and drug product
Based on extensive use of outsourcing, I can assist with CMC development related to:
- Contract Manufacturing Organisation (CMO) contact, selection and coordination of agreed CMC activities
- Initiating required development activities related to specific development phases
- Coordinating development activities, e.g. Stability studies, analytical methods, specification development, clinical trials supply, IMPD preparation