Our client base is very diverse as we serve in many areas. We have provided a few examples of our work so it’s possible to get a more specific idea of what we do and how we work with companies to achieve the desired results.

Startup Funding Project

A small drug development company whose main focus is developing therapeutics to treat acute exposure to radiation and treatment for the exposure to various chemical and biological agents was in search of funding.  With only days before a grant submission deadline was due to the Army Research Office, QIS, Inc. stepped in to assist with the technical writing, creating and reviewing the lengthy technical and financial proposal that normally would take weeks to write. With extreme focus and dedication, this proposal was submitted within the deadline and the client was very grateful. 

Successful Laboratory OOS Investigation

A combination drug/device company was working diligently on commitments they had made in an FDA warning letter response.  The company needed help with the management and execution of their largest ever CAPA that involved a global root cause investigation in the laboratory, manufacturing, vendor supply chain, as well as raw material and components that spanned many countries.  Dr. Hartzfeld provided expert knowledge and hands-on assistance in the execution and documentation of the root cause investigation events and findings.  She also compiled the large body of information into a very organized structure that enabled a clear and concise understanding of the complicated CAPA file.  The outcome of the engagement resulted in the successful FDA review of the CAPA file on several occasions and ultimately the client met their commitment within the warning letter.

Installed Design Controls Program

A small medical device start-up was ready to phase out of research and development and into the cGMP manufacturing environment.  They lacked the knowledge on how to move forward in an FDA regulated fashion.  QIS provided customized training sessions to all levels of the organization from Executive Management, to the Engineers and Scientists.  In a very rapid timeline, QIS taught the firm about regulatory 510(k) filings, the requirements of CFR Part 820 to manufacture a medical device and how to properly control information and records .  QIS assisted with the development of a comprehensive Quality Plan, the installment of a Design Controls Program and many other procedures required by the QSR.  The company saved time, costs and readily realigned their business goals to include the CFR Part 820 Quality System Requirements.  The activities prevented the company from losing time and money and got them on the proper track to working with the FDA regulations.

Implemented Quality System Program

A mid-size API manufacturer was not operating within cGMP compliance and was going to compromise the outcome of their customers’ upcoming PAI inspection.  Dr. Hartzfeld upgraded and optimized the Analytical Laboratory including procedures, forms, logbooks, test methods and validation programs, equipment qualification program, USP monograph verification program, equipment calibration and preventive maintenance program, sampling handling, reference standard program, laboratory investigations and facility environmental controls. She then extensively trained the seven (7) analysts on how to work effectively within these quality systems, and retrained the analysts on their analytical skills, techniques and wet chemistry test methods.  Dr. Hartzfeld provided hands-on mock audits to prepare the laboratory staff to interacting with FDA inspectors. As a result, the lab operated in cGMP compliance, laboratory investigations were drastically reduced due to fewer laboratory errors, the firm passed the PAI inspection with zero FD-483 citations.

Technical Writing that Sustains Time

A company wanted to upgrade their facility to manufacture cGMP drug substance and drug products, but their Quality Assurance program had many critical deficiencies.  Dr. Hartzfeld wrote over 200 QA/QC procedures, forms, logbooks and training documents to optimize the companies’ Quality Assurance and Quality Control documents and records for a Phase III/IV manufacturer.  The company was able to manufacture under a compliant Quality Assurance program that has sustained time.  Six years later the company is still operating using the same documents and procedures, effectively executing biennial reviews and submitting comprehensive Annual Product Reviews to the FDA.