Effective Strategies for Sustainable Biologics Compliance

Achieving total quality and sustainable compliance for biologics in a dynamic regulatory environment, including current Good Manufacturing Practices (cGMP), requires not only expertise in relevant regulations and laws but also a deep knowledge and practical experience in the development and manufacture of these products. Effective compliance is ensured through a combination of scientific and technical knowledge, regulatory expertise, and hands-on experience, which allows BQRC to exceed the minimum requirements of international regulatory authorities. BQRC offers this expertise, embodying a philosophy of "Compliance Through Science" with a focus on good scientific practices and practical common sense.    

Strategic planning during the development of innovative biological products is crucial and involves a strong understanding of science, processes, critical quality attributes, critical process parameters, and regulatory guidance. BQRC emphasizes the use of scientifically sound analytical methods and modern technologies such as proteomics, genomics, and advanced microbiological methods to enhance testing and characterization. This approach improves accuracy, precision, and speed, ultimately leading to faster market entry and better product safety and efficacy. Additionally, BQRC values the importance of mentoring and training staff, believing that a deep understanding of their roles and the impact on product quality is essential. The team’s scientific, regulatory, and interpersonal skills are geared towards effective staff training and decision-making to achieve the organization's vision and mission.