A kickoff meeting is an opportunity to introduce you to our project team, review the project brief, discuss milestone expectations, and how to make the project a success. This meeting happens before the project scope of work is initiated.

At this phase of the project, we will ask you to submit key documents, diagrams, and/or videos related to the project. This could be for example, an organizational chart, facility diagram and/or video footage, SOPs, product list, production records and/or video footage, training records, environmental monitoring data, regulatory/accrediting body application/inspection report, etc. Submitting this information is a rate-limiting step to moving the project forward. To make the process easier, you will be granted access to our private HIPAA-compliant portal, where you can securely submit the information and files requested.

Once the files have been shared, our project team reviews the information submitted, conducts project-specific research if applicable (e.g., market research, on-site gap analysis audit, formulation development, etc.), and makes an assessment as to the changes or additions that need to be developed and delivered to your company to meet the project goals.

If any major revisions, additions, or remediations are necessary to make the project a success, our team will alert your company at the time of finding.

The last step of the process is to develop and submit the deliverables (e.g., customized SOPs or protocols, CAPA plan and implementation, gap analysis report, etc.) according to the projected project timeline. Documents created will be submitted through the client portal. Other deliverables will be performed per project needs (e.g., staff augmentation, personnel training, expert witness testimony, etc.).