At PSC Biotech, we pride ourselves in providing comprehensive regulatory compliance and validation services. Our services include strategic planning, commissioning and qualification activities – which include Equipment Qualification, Computerized Systems and Software, Processes, Cleaning, and Analytical Method Validation.
We have experts in regulatory compliance who understand FDA, EU, ICH, and PICS requirements. Whether you are a highly experienced organization looking for resources to supplement your own staff, or you are a company looking for specific expertise in an area new to you, PSC Biotech can assist you. Our highly experienced staff can help you prepare for a pre-approval inspection, bring new facilities online, bring products to commercial market, and meet your commitments to the regulatory organizations. Click on any of the specific services below for more detailed information.
We offer a full range of validation services, including:
- Validation Master Plans
- Validation Protocols / Reports / Field Execution
- Computerized System and Software Validation
- Cleaning Validation
- Equipment Qualification
- Facility Qualification
- Process Validation
- Utility System Validation
- Shipping and Packaging Validation
- Test Method Validation
If you have any specific questions about us or any of our services, get in contact with us directly here.