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Our comprehensive services include all aspects of commissioning, qualification, validation and regulatory compliance.
Whether the project involves getting a whole new facility in operation and in compliance, adding a single piece of equipment, or getting back into production after a shutdown, we provide a comprehensive set of essential services. We are a single-source compliance resource for our clients.
Our primary services include:
Commissioning and validation of pharmaceutical manufacturing equipment, systems, and facilities. Our experience encompasses bulk pharmaceutical chemicals, biotech process equipment, sterile bulk and sterile finished dosage forms, dry products, cleaning, sterilization, computer systems, animal facilities and other areas of pharmaceutical manufacturing.
- Process analytical technology (PAT) and other
manufacturing process improvement services.
- Regulatory and cGMP Compliance services
- Computer software development and validation, including LIMS, DCS, SCADA/PLC, databases, and other applications.
- Project delivery services such as project management, commissioning or validation coordination for large and small projects, equipment integration engineering and expediting, and other specialized services.
- Production support services such as SOP writing, technical training, or maintenance program development.
We serve Fortune 500 companies (and some that will be in the future) Our clients include some of the largest pharmaceutical companies in the world. We also serve smaller companies and start-ups that are ready to launch their first product! Due to our performance and high degree of customer satisfaction, the majority of our business is from repeat customers.
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