Constant communication, budget and schedule updates, real-time field and budget updates should be expected and will happen. We utilize the utmost in field technology with transparency for all stakeholders.

• Our expertise spans the entire lifecycle of facility development, including comprehensive technical writing supportfor processes and procedures within the cGMP/GMP suite. This service ensures that our clients have access to clear,concise, and compliant documentation, which is crucial for regulatory approval and operational success. Moreover, we offer tailored User Requirement Specification (URS) assistance and writing, focusing on the specific needs and goals of each client. This personalized approach simplifies the compliance journey and enhances the facility’s operational effectiveness.

• At the core of our methodology is a robust Quality Assurance (QA) plan that covers every aspect from material receiptverification to critical systems and components checks and commissioning. Documentation throughout the process isrequired. This meticulous attention to detail not only facilitates FDA compliance but also offers significant schedulingsavings during the Commissioning, Validation, and Qualification (CVQ) processes. By optimizing these critical phases,we enable our clients to transition more swiftly from construction to full-scale production, thereby reducing downtimeand accelerating time-to-market.