The request for proposal
If you have a process development, manufacturing or aseptic filling project that you wish to discuss with HALIX, the first step is to contact our Business Development team. HALIX will work with you to initially determine the level of fit between your project objectives and HALIX service offering and expertise.
The Business Developer will interface and be your point of contact, managing your and HALIX expectations throughout every step of the CMO selection process. A 2-way confidentiality agreement will be put in place to discuss the full details of the project supporting an in-depth technical appraisal of the scope of work necessary to meet project success criteria and for HALIX to estimate the resources and provide the work program, timelines and prices of the services required in the form of a proposal.
A formal Request for Proposal detailing your service requirements and clear project objectives is always preferred, but if not available, HALIX can provide a questionnaire to help steer the program to be discussed at the right level of detail.
Following discussions with HALIX technical experts to define and meet the project requirements and deliverables, HALIX will evaluate thoroughly and upfront as to whether your project can be successfully accomplished by HALIX. A formal proposal will then be written and submitted to you.
This proposal will detail the process and analytical transfer and/or development activities, the scale-up strategy and any qualification/validation needs, in order to manage the quality, risk and costs of bulk drug substance and/or drug product manufacturing at the production scale in the GMP facility. Furthermore, timelines and expected costs of each stage for the requested project will be presented in a transparent and easy to understand way.
Upon selection of HALIX as your outsourced manufacturing partner, a project team will be assembled representing specific functional areas require for the project.