Regulatory Approval

Our Client: Small pharmaceutical firm seeking regulatory assistance. Full case study

Our Client: Chemistry and Manufacturing Controls (CMC), a virtual start up company, engaged Safis to act as their regulatory affairs function as well as to develop a solution to change manufacturing processes to remove ASMs. Full case study

Quality Compliance

Our Client: A small pharma company engaged Safis to establish Quality Systems. Full case study

Our Client: A laboratory testing company needed to establish Quality Systems. Full case study

Our Client: A major university discovered a need for regulatory guidance and compliance oversight. Full case study

Our Client: A small biotech start up company required quality and regulatory guidance. Full case study

Validation

Our Client: A large device and diagnostic company chose Safis to deliver ongoing quality and validation services. Full case study

Our Client: A large Midwest University Medical School was contracted by an international manufacturer to conduct a clinical trial for a new product designed to reduce cavities in dental patients. Full case study

Our Client: A medical device company engaged Safis to validate an IVD (in-vitro diagnostic) assay. Full case study

Our Client: A large pharmaceutical company engaged Safis for software validation services. Full case study

IT Services

Our Client: A large pharma company required assistance in creating several intranet websites for internal employee use. Full case study

Audit & Remediation

Our Client: A laboratory was working with a pharmaceutical company to provide clinical trial sample analysis services. The pharmaceutical company was scheduled to perform an audit of the laboratory company. The laboratory client requested that Safis Solutions audit their processes, documentation, and overall quality system. Safis evaluated the Client’s quality systems relative to GxP regulations. Full case study