Consulting

Our process engineering is a specialized field of engineering that focuses on the design, development, optimization, and management of industrial processes. It involves applying scientific and engineering principles to design, improve, and troubleshoot processes in a wide range of industries, including chemical, pharmaceutical, food and beverage, and oil and gas. Process engineers work to maximize efficiency, safety, and profitability, while minimizing waste and environmental impact. They are responsible for developing and implementing new processes, as well as improving existing ones, to ensure that products are manufactured in the most cost-effective and efficient manner possible.

Drug substance manufacturing is the process of producing the active pharmaceutical ingredient (API) in a drug. This process involves a series of chemical reactions and purification steps to produce a pure and stable form of the drug substance. Drug substance manufacturing is a complex process that requires a high degree of expertise in chemistry, engineering, and quality control. It is critical to the production of safe and effective drugs, and must adhere to strict regulations and guidelines set forth by regulatory agencies such as the FDA. The drug substance manufacturing process is a key step in the overall drug development process, and plays a crucial role in ensuring the safety and efficacy of pharmaceutical products.

Drug production manufacturing is the process of producing finished pharmaceutical products in large quantities. It involves several steps, including formulation, manufacturing, and packaging. This process requires a high degree of precision and quality control to ensure that the final product is safe, effective, and meets regulatory standards.

DEA controlled substance programs and auditing are critical components of drug manufacturing and distribution. These programs ensure that controlled substances are handled, stored, and distributed in compliance with DEA regulations. Auditing helps identify and mitigate any potential issues or violations, and ensure that the program is being executed correctly.

Strategic and facility master planning are essential for ensuring that an organization is well-positioned to meet its goals and objectives. This process involves analyzing current operations, identifying areas for improvement, and developing a roadmap for achieving long-term success. Facility master planning focuses on optimizing the physical space and infrastructure to support the organization’s needs.

Engineering feasibility studies are conducted to evaluate the feasibility and viability of a proposed engineering project. This process involves analyzing technical, economic, and environmental factors to determine whether the project is technically and financially feasible, and whether it aligns with the organization’s strategic objectives.

cGMP change management is the process of managing changes to a cGMP system. This includes identifying and assessing changes, implementing and validating changes, and ensuring that the changes are documented and communicated appropriately. This process helps ensure that cGMP systems are maintained and improved to meet regulatory standards.

Cost benchmarking is the process of comparing an organization’s costs to those of its peers or competitors. This process helps identify areas where the organization may be over or under spending, and can help identify opportunities for cost savings and process improvements.

Operational readiness, strategy, and planning are essential for ensuring that an organization is prepared for operational success. This process involves developing a clear strategy, identifying key performance indicators, and developing processes and procedures to ensure that the organization is well-positioned to meet its objectives. Operational readiness planning focuses on ensuring that the organization is prepared to execute on its strategy, and that all necessary resources are in place.