Bionova’s Quality Principles enable sound, timely decision making that supports our clients’ needs and conform with regulatory guidelines and requirements.

Quality as an accelerator

We are always mindful that speed is critical for our clients, and we want Quality to enhance speed. At Bionova, we work with our scientific, engineering and operations colleagues to ensure intelligent risk management. We right-size the oversight, approach to match the client’s specific situation, resulting in faster and better outcomes.

We provide full validation support for client processes and products, including any specialized equipment, instruments, or conditions.

Technically experienced quality specialists

Our quality specialists have deep technical expertise to actively participate with Bionova’s functional groups. Our ability to advise on quality issues with detailed understanding of technical and scientific tradeoffs is an important contributor to Bionova’s organizational agility.

Our Quality team brings extensive manufacturing experience to Bionova. We know manufacturing and process development, so when we spend time in the plant, we are advising, analyzing, and deciding. Because our systems are largely paperless, we spend our time on the floor adding value for the client.

Planning means efficiency

The Bionova Quality team engages with client projects at the earliest stage. Starting at the proposal process and assessing the scope of work so we can design the appropriate level of quality management into each project. By understanding client needs upfront (e.g., EMA vs. FDA, Early Stage vs. Late Stage) we can apply suitable quality requirements and ensure the most efficient approach.

Client access

Bionova understands that our clients want frequent and secure access to information about assays, batches, and materials. Bionova Technical teams provide daily readouts on cell culture and purification and Bionova Quality teams provide access to electronic records so clients can comment and revise directly in our system.

Our electronic quality management systems enable direct client access for transparency with security.

Biopharma Resilience: Bionova Scientific talks capacity, speed and agility needs - Video