The pressure to reduce time to clinical and time to market makes moving through development phases in a seamless and robust manner a priority. Our novel FASTPHASE™ program for small molecules deliver your requirements with speed. We can prioritize and meet important milestones, such as filing the IND, generation of data and reports to help secure additional funding, generating safety, formulation and stability data with all the confidence your project needs, ensuring robust supply of clinical materials and seamless scale up and validation programs. FASTPHASE™ is designed to help you reduce the time it takes to get your program to critical milestones and is designed for speed and flexibility whilst maintaining the highest quality standards and continuously de-risking your program.
FASTPHASE™ Project Managers are dedicated to your project. They focus on getting to know your needs to find out what would make the project successful. This include timelines, quantity, quality, and project specific requirements. The Project Manager is your voice and manager who will drive your project through the FASTPHASE™ system.
Under FASTPHASE™ your project is resourced through a dedicated multidisciplinary team including made up from our analytical and process development teams as well as a dedicated production and quality group to make sure that everyone is working to best meet your needsand deliver to timelines in accordance with your needs.
Our FASTPHASE™ program includes the assignment of a member of the senior management to facilitate prioritization and resource allocation. Once the FASTPHASE™ program and timeline is set the team will be dedicated to ensuring delivery according to plan. The senior manager supports the project manager in making sure delivery is achieved to schedule.
FASTPHASE™ is designed to not compromise quality, and regulatory requirements are built into every milestone of your project. Quality is assured in the program and our teams include regulatory, quality assurance, quality control and results and documentation are prioritized for review and approval.
Silke is a trained biologist with 20 years of experience in leadership of multifunctional teams and project management in pharmaceutical drug development. She has been working at Magle Chemoswed since June 2019.