Problem Statement
Client 1: An early-stage virtual (discovery stage) pharmaceutical company, developing novel small molecule drug candidates needed the Quality unit to support the IND enabling and Phase 1 studies. The company did not have a quality unit in place. All the operations for GLP studies and GMP manufacturing were outsourced to different contract labs and contract manufacturers. Client 2: An early-stage virtual (discovery stage) biopharmaceutical company developing therapeutics antibodies, needed the Quality unit to support the IND enabling and Phase 1 studies. The company did not have a quality unit in place. All the operations for GLP studies and GMP manufacturing were outsourced to different contract labs and contract manufacturers.
Expertise And Solutions
The client company hired us to act as their Quality unit and build the quality unit from scratch. We build a quality team with relevant expertise for project execution. We developed a comprehensive quality strategy and roadmap and presented it to the client for approval. The quality strategy included the list of Quality systems, which will be developed for the phase 1 product, a plan for implementation of quality systems, a risk-based auditing approach for the supplier’s list provided by the client, a risk-based approach for the development of Quality agreements, supplier quality oversight, and product release. Once the plan was approved by clients, our team started the execution of the plan. We qualified all GLP and GMP suppliers. We worked with clients, clients’ legal department, and their outsourced partners to develop quality agreements. We developed and implemented the required quality management systems and trained clients on the quality systems. After that, we conducted basic GLP and GMP training for clients and employees. All the basic system set-up and qualifications were completed in 3-4 months. After that, one of our team members was dedicated to the client who attended all client meetings with suppliers, provided quality advice, reviewed/approved documents, and conducted clinical trial material release. Thereafter, ongoing quality and batch release support was provided as the product moved from discovery to phase 2.
Results
As a result, the client was able to have an as-needed quality unit at a lower cost, instead of hiring a full-time quality unit during the early phases of product development. Once the product started moving to the late phase, the company hired its own quality unit to manage quality and we the newly hired Quality staff on processes and systems.
Feedback
The company’s CEO and leadership team were satisfied with the quality support provided by our team in the early phases of product development and continued to work with us during the late phases of product development as additional quality support was needed on an ongoing basis. The company’s leadership was particularly impressed by how we were able to complete the Quality unit set-up within a few months at such a low cost. That was due to our expert staff and the tools (Intellectual Property) we built internally to deliver results, on-time and within budget. In addition, we have supported about 10 discovery-stage clients and acted as their quality unit at an early stage of product development.