Custom Pharma Services project managers form a critical part of each project, ensuring that every programme is delivered on time and in full. Your project manager will coordinate every process in each phase of your programme to meet your timelines and budget. As a key member of your product and process development team, your project manager will ensure all your technical requirements are met and will work with you to resolve any regulatory challenge you encounter.
All of our project managers have more than a decade of experience within the pharmaceutical industry, having managed programmes from both clinical and commercial sectors. Custom requires that our project managers be Prince2 certified to apply these principles across all our client programmes. Custom also ensures that the team is highly knowledgeable in the principles of Good Manufacturing Practices, Good Distribution Practices and clinical trial supply management.
We consider our work to help bring lifesaving and life-enhancing products to the market to be an honour. That’s why our project managers treat every programme as if it is their own. We will communicate with you at every stage, updating you on the progress of your project at every stage throughout the development life cycle and responding quickly and appropriately to your specific needs.
A systematic and thorough Due Diligence process is vital in maintaining and expanding your business capabilities. If you need help with your existing or future product, we also offer technical/analytical reviews of CMC (Chemistry, Manufacturing & Controls) – part of pharmaceutical (human & veterinary) dossiers.
Custom’s knowledgeable core team of technical and analytical experts provide support in the following areas:
- Review of the Dossier’s technical and analytical completeness – initial review of the data to gain an understanding of the materials available and the expertise required to cover potential deficiencies and providing you Custom’s offer (fee) for the service;
- Perform gap analysis of the data from technical & analytical aspects, identifying technical/analytical deficiencies in the Dossier;
- Review of consistency of technical and analytical records in the Dossier;
- Evaluate technical data chemistry/manufacturing/analytics;
- Review of manufacturing processes & validations;
- Review of analytical methods & validations;
- Review of stability studies.
Upon review we shall provide you a full report on our findings with appropriate recommendations, detailing and estimating the work, which based on our expertise and opinion is necessary.
Custom is also in a position to offer its skills and services to remedy any technical or analytical gaps revealed during the review and if agreed, will generate and provide you supporting documentation in an agreed format to update your Dossier in compliance with current EU requirements.
Please contact Eva for more information!