Quality Assurance Programs & Solutions
We offer specialized consulting services to help both 503A and 503B pharmacies build and optimize their Quality Assurance (QA) Programs. Our expertise ensures your operations not only meet but exceed the rigorous standards set by the FDA and other regulatory bodies. We understand the unique challenges faced by compounding pharmacies and provide tailored solutions to guarantee compliance, efficiency, and patient safety.
Regulatory Evaluations & Audits
We provide comprehensive Regulatory Evaluations and GAP Analysis to help you proactively identify and resolve potential compliance vulnerabilities. Our expert consultants conduct detailed Mock FDA and Pre-Inspection Audits, simulating a real regulatory review to stress-test your systems, policies, and procedures. This process gives you a clear roadmap to address any weaknesses, ensuring your facility is fully prepared and confident for official inspections, and turning the audit process from a point of anxiety into a demonstration of your commitment to excellence.
Vendor QUALIFICATION & Management Systems
We offer comprehensive services for developing and implementing robust Vendor Qualification and Management Programs. Our expertise ensures that your suppliers meet rigorous quality standards from initial selection through ongoing monitoring. We help you create a proactive system to audit, qualify, and manage your vendors, safeguarding the integrity of your supply chain and ensuring all raw materials, components, and services comply with Good Manufacturing Practices (GMP) and FDA requirements. This strategic approach protects your product quality and mitigates risk, transforming your vendor relationships into a source of confidence and reliability.
Pharmaceutical Formulation Design & Development
Our Pharmaceutical Formulation and Design services are specifically tailored for the critical pre-commercialization phase. We partner with you to develop robust and stable drug formulations, focusing on activities like process optimization, stability studies, and scale-up planning. Our goal is to bridge the gap between initial research and full-scale manufacturing, ensuring your product is not only effective but also reproducible and compliant with all regulatory standards. This proactive approach helps to mitigate risks, accelerate your path to market, and build a foundation for a successful product launch.
Production Process DEVELOPMENT & Optimization
Our Production Process Development and Optimization services are designed to transform your initial concepts into scalable, efficient, and compliant manufacturing processes. We focus on every critical step, from pre-clinical development through to commercialization, ensuring your process is robust, reproducible, and cost-effective. By leveraging our expertise in process scale-up, technology transfer, and Quality by Design (QbD) principles, we help you identify and eliminate bottlenecks, reduce waste, and improve overall yield. Our goal is to streamline your path to market and build a manufacturing process that not only meets rigorous GMP and FDA standards but also provides a sustainable competitive advantage.
Facility Design & Automation
Our Facility Design and Automation services provide a strategic approach to creating and optimizing manufacturing environments for all types of pharmaceutical production. With specialized expertise in Sterile Parenterals, Oral Solid Dose, and Blow-Fill-Seal operations, we ensure your facility is not only compliant with GMP regulations but also maximizes efficiency and minimizes risk. We integrate advanced automation and control systems from the earliest design stages, creating a seamless and intelligent production flow. Our comprehensive approach ensures that your facility is built for a future of high-quality, high-volume manufacturing, regardless of the product type.