Scope of Work and Sales Process

Each project is unique and often requires a different mix of our services. That's why we've devised a process to make sure that we always focus on our customers' precise needs.

Throughout the sales process, our goals are to:

Establish clear lines of communication
Ensure that we thoroughly understand all customer needs (product, process, technical, regulatory, clinical, commercial/financial, and timing)
Ensure that our customer thoroughly understands our services, practices, policies and procedures, and philosophy
Carefully align expectations
And we jointly design the work program and establish joint "ownership" of a mutually agreed upon Scope of Work

Confidentiality Assured

Diosynth will be happy to discuss your request at a high level and provide general guidance regarding the program before a CDA is in place. In order to ensure confidentiality of our discussions, we do not undertake detailed discussions or exchange specific information until a CDA is executed.

CMO Selection Process

As you embark on the search for your CMO, customers seek assurance that Diosynth Biotechnology can indeed meet their requirements. We will be diligent in our efforts to help with your assessment so you have the utmost confidence when selecting our organization.

Once we have mutually established that there is a "fit", we can prepare an initial business proposal to address your specific need. This proposal, which would be based on detailed technical information about your product and program, will address:

Do we agree on the program objectives and timelines?
How does Diosynth propose to address these needs?
What is the program design? What are the activities, deliverables, the timeline for completion and estimated budget for the program?
What are the critical issues? What can Diosynth recommend based on our experience in this industry and possible constraints with similar programs?

We understand that evaluating and selecting the right manufacturing partner is a critical step. We see this initial proposal as a stepping stone. We expect to discuss this proposal further with you and mutually develop the right solution to meet your needs. During such detailed dialogue, we hope to provide you with all information and support you need during your CMO selection process.

Formal Agreement

According to ICH guidelines, sponsor and manufacturer must reach a formal agreement before the work is performed. If you choose Diosynth as your manufacturing partner, we can efficiently guide you through the agreement process. The formal agreement would include documents that define each party's technical (Scope of Work), quality/regulatory (Quality Agreement) and legal/business (Terms and Conditions) responsibilities. We would jointly translate the business proposal into a Scope of Work document that outlines Diosynth Biotechnology's activities and deliverables, including detailed timeline and firm pricing.

Program Performance

Now we can begin work! We realize that good communication is crucial during project execution. Experienced Customer Project Leaders (CPLs) and Core Project Teams will manage your program to ensure timely completion of mutually agreed Scope, within established budget. We promise that you will be kept abreast on the progress of your project, and that we will support you fully to make informed decisions that relate to the project.

See also