Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from poor team selection and inadequate time and resources, which also applies to quality control (QC) partners. However, there are three key characteristics that reliable QC professionals bring to the table in a drug development organization’s process of creating new pharmaceutical products. These characteristics significantly improve the odds of regulatory approvals.

Characteristic 1: Skilled and Trained Team Members

Industry expertise and experience play a crucial role in QC consulting. These professionals are often engaged in an ad hoc manner or embedded within companies for a period. In either case, it is essential for hiring managers to foster an environment of openness and cooperation between the consultant and the staff. Startups and small companies often need experienced outside consultants to provide specialized skills on an as-needed basis. They identify and mitigate potential gaps that may be overlooked by employees without those perspectives. Health authorities often require external QC consultants to review organizations’ quality systems and mediation plans in the face of actions taken around regulatory issues.

Characteristic 2: Proficiency in Root Cause Analysis

Thorough root cause analysis is critical for the development of effective corrective action plans. QC professionals rely on a range of statistical and nonstatistical tools, such as data trending, regression models, and graphical methods to efficiently analyze data and identify a problem’s underlying causes. This analysis allows them to develop correction plans that address these causes and reduce the likelihood of future occurrences. A deep understanding of root cause analysis also contributes to the creation of comprehensive corrective action plans that include detailed information on processes, causes, potential preventative measures, ownership of responsibilities, timelines, deadlines, and budgetary considerations.

Characteristic 3: Flexibility and Collaboration

Consultants who drive success in pharmaceutical development are adaptable and recognize when additional expertise is required. They foster a spirit of collaboration that addresses and resolves quality gaps, establish robust standard operating procedure (SOP) templates, and develop policies and procedures tailored to the specific needs of the company. In addition, they train employees and integrate procedures into day-to-day activities. The impartial expertise provided by external consultants offers valuable insights into establishing, defining, and documenting all activities related to product development, approval processes, and launch. They can also facilitate mock audits ahead of actual external audits and reviews, “practice runs” that can impact success. Moreover, engaging external expertise enhances the chances of obtaining quality certifications at an early stage.

Prepped for Success

The pharmaceutical industry is highly competitive, and the success of both startups and established firms’ product development depends on adopting the right approach and strategy. Partnering with proven experts with unique skill sets is essential to successfully developing new drugs. These experts possess a deep understanding of causation and solutions, creating a flexible and collaborative work environment where all team members seamlessly work together towards common goals. By utilizing these key characteristics, biomedical startups can position themselves for success and make significant contributions to improving quality of life through innovative products.