The Request For Proposal (RFP) Process

The general process of getting a project price quote or proposal to the start of manufacturing/filling is described below:

Defining your project

  1. Contact Florida Biologix (FB) with a potential project
  2. Discussion to determine if our capabilities and schedule are a fit for your project needs and timeline
  3. Enter into optional non-disclosure (confidentiality) agreement
  4. Fill out FB project questionnaire or send us a Request for Proposal (RFP): This details the type of material, handling specifications, scope of work and timeline for your project
    • Please provide as much detail as possible about:
      • the material (safety, consistency) or cell line (source, identity etc.)
      • any raw materials, solutions or media to be used
      • growth characteristics of the cell line
      • the formulation, manufacturing or filling processes (unless FB is developing the formulation/process)
      • testing required
      • storage and shipping requirements
    • An MSDS or other documentation demonstrating product identity or safety is required

    Example questionnaires:

Developing your Project

  1. Conference call to discuss project specifics to so that FB can generate an estimated pricing proposal.
  2. Detailed pricing proposal generated, reviewed and if accepted, your space in our facility is secured.
  3. Site audit for sponsor to evaluate facility, quality systems and staff (recommended).
  4. Project kickoff meeting held to finalize specifics for initial Process Development (if any) or to confirm what will be written into GMP batch records.
    *Note that all batch records and other documentation will need to be reviewed and approved by your organization in a timely manner in order for the project to proceed on schedule
  5. Document preparation for the manufacturing/filling process begins. Florida Biologix maintains close communication with project sponsor throughout this process and the entire project.