Regulatory Support

Trusted Experts in Navigating Biologics Regulatory Affairs

Cytovance Biologics has a strong history of regulatory compliance throughout all stages of the product lifecycle. As part of our commitment to a healthier world, patient safety is our primary concern, and we ensure all production processes are designed for optimal clinical and regulatory outcomes.

Aligned for Excellence at Every Phase

Whether it is advising on pre-IND meetings or assisting clients to prepare for chemistry, manufacturing, and controls (CMC) selection, our seasoned quality team has decades of experience in biologics development and manufacturing to successfully guide you through the complex needs of regulatory bodies. Every phase of the manufacturing process comes with regulatory implications, and we know the importance of setting up a strong quality program to ensure compliance at every step on the path to commercial approval and improving patients’ lives.

Navigating the Regulatory Roadmap

The journey through regulatory affairs is often filled with hurdles. At Cytovance, we are poised to assist clients throughout the entire process and position them for regulatory success by offering all critical services for CMC compliance in-house. Our capabilities include manufacturing process validation, quality control release testing, product characterization, and stability testing. We host numerous regulatory and client-driven quality audits each year and can provide you with absolute confidence in our processes and facilities.

Strong Quality Management System

From preclinical to commercially approved phases, our established systems guarantee integrated process control for efficient and reliable project execution. Relying on committed collaboration and communication across all departments, Cytovance’s Quality Management System and MasterControl document solution, strategically and systematically control all activities to ensure that domestic and international quality requirements are fulfilled for your product.

Proven FDA Track Record

Cytovance’s approach to biologics regulatory affairs has been validated through the success of past client programs and FDA audits. Over the years, we have supported 350+ APIs in clinical trials, 200+ client programs globally, and three commercially approved drug products. We provide procedural and operational excellence across our organization to ensure all relevant regulatory compliances are met so that your product can successfully transition to clinical and commercial stages.