CMC- Process Development

IIn pharmaceutical process development, selecting the appropriate manufacturing process is crucial and should be closely aligned with the chosen dosage form. A streamlined approach is essential; the process should be as straightforward as possible, minimizing unnecessary steps that could complicate production or introduce variability. By utilizing well-established techniques that are commonly available in most Contract Development and Manufacturing Organizations (CDMOs), companies can ensure that they will find a reliable manufacturer with an affordable price. Additionally, the chosen process must facilitate easy scalability to accommodate the target batch size for the marketed product, ensuring that production can meet commercial demands without compromising quality and with minimal resources required for scale up optimization.

At Tandem BioPharma CMC Consulting services, we specialize in process development that aligns with these critical requirements. Our focus is on the final marketed product from the outset, ensuring that the processes we develop are not only efficient and straightforward but also scalable and robust. By integrating these principles into our approach, we strive to deliver high-quality pharmaceutical solutions that meet the needs of our clients and the expectations of regulatory bodies.