The Drug Production Process | Rondaxe

  

Development, Optimization and Validation of Drug Processes

Our specialized drug process development, optimization and validation services are available as part of our integrated services. These include feasibility studies, clinical trial manufacturing, commercial production of therapeutic ingredients, intermediates and finished drug products, among other things.

Developing medicine manufacturing procedures which can generate the next generation of breakthrough pharmaceuticals is critical right now. The ability to fulfill stricter and increasingly specialized product criteria is more important than ever. These processes must be inventive, efficient, dependable, and cost-effective in order for you to remain competitive. To achieve these requirements, our professionals provide complete process development services which continuously increase the operational efficiency of your medicinal product manufacturing operations.

Comprehensive Development Support

It is vital to consistently meet product standards while ensuring effective process intensification, to keep production costs at a minimum. Our professionals offer complete medication process development services which help you continuously increase your operational efficiency so as to achieve these requirements.

Choosing the Best Manufacturing Method and Supporting Technology

Process development starts with selecting the most appropriate process and supporting technologies during product design. It then continues through each step, including scale-up from bench and pilot-scale to commercial production under current good manufacturing practices (cGMP).

Our interdisciplinary product development teams are well-versed in the interaction between these following elements:

• Material science/design and functioning

• Product development and optimization

• GMP standards

• Process development and management

Simplify the Procedure and Minimize the Need for Modifications

Because we have the facilities, technology, and services to bring a product from conception through commercial development, process-development choices are made with the ultimate aim of commercial production – even if they’re made right in the development process. As the drug candidate progresses through the development process, this strategy simplifies the entire process, lowering the need for formulation and process adjustments.

Various cutting-edge process-development tools and assessments are used in our approach to process creation and optimization:

• Process assessment techniques that are computer-assisted

• Methods for scaling up and down for certain unit processes

• Analytical technique development in support of quality assurance and quality control operations

• Process evaluation and troubleshooting to increase process efficiency

• Support for implementing and maintaining standards of current Good Manufacturing Practices (cGMP)

• Process analytical tools that improve the efficiency, productivity and dependability

• Investigating and resolving production challenges in real-time across a wide variety of unit activities

Visit rondaxe.com for more information on the drug production process or call us in New York at (315) 469-2800 today.