Virtual Start-up Pharma Company (Company A) has 10 employees and has been relying totally on vendors and CMOs services during the development, pre-clinical studies and manufacturing of its new drug. Company A has no quality department and no quality system in place but needs to have one before its first IND submission to comply with FDA requirements.
Company A: had limited budget and wanted to implement a simple and tailored QMS within 2 months before submitting its IND to FDA.
With its extensive experience in setting up and implementing Quality Systems for start-ups and small life science companies, Global Regulatory Partners (GRP) was able to set up the appropriate QMS for the virtual company within the time frame of 2 months and the Company was able to file its IND to FDA immediately after the completion.
GRP performed the following activities to meet the Company goal:
- Conducted Quality audits of the Company A and its major and critical suppliers and vendors to better understand the responsibilities and resources of the different parties.
- Mapped the different process such as manufacturing process, supply chain.
- Selected and implemented the appropriate electronic system for documents management and control.
- Wrote a full set of core SOPs that cover all the activities performed by the company.
- Rolled out the SOPs in 3 waves based on priorities.
- Trained all employees on SOPs.