Program Partner

More savings. More research.     888.246.1728   •

Member Benefits on FDA/Regulatory Services

10% discount on all professional services, such as:

  • Commissioning, Qualification and Validation (CQV) Planning, Document Generation and Execution Support
    • Factory Acceptance Testing (FAT’s)
    • Review and Preparation of Validation Master Plans
    • Writing CQV Plans / Generating CQV documentation (IQOQ PQ) / Executing CQV documents
    • Facility, utility, and equipment CQV protocol execution
    • Resolving Deviations / Change Management
    • Writing Final Summary reports
  • Computer System Validation and Assurance, and IT Infrastructure support
    • eQMS System Validation and Integration
    • ERP (such as SAP) Validation and Integration / BMS Validation and Integration (Delta-V, Siemens, etc..)
    • Data Integrity Gap Assessments/Audits
    • Serialization support for packaging regulations (Validation and Integration)
  • Regulatory Affairs
    • Regulatory Strategy
    • Provide Guidance on Regulations and Standards / Generate and Manage Submission Files and Review 
    • Review and Maintain Project Documentation and Records
    • Participate in Risk-Benefit Analysis for Regulatory Compliance / Gap Assessment and Audits
  • Quality Assurance
    • QA Oversight - Investigations / Non-Conformance Reports / CAPA’s / Change Control / Training Compliance, Training and Support / Quality Agreements / SOP writing
    • Review and Approval of Validation Documents
    • Regulatory Inspection Remediations / Regulatory Documentation
  • Audits and Gap Analysis 
    • Supplier 
    • Turn-Key Supplier Qualification Program Support
    • Safety 
    • Laboratory
    • Facility
    • PAI Preparation
    • cGxP
    • Gap Analysis
  • Calibration
    • Field instrument calibrations
    • Calibrations in our metrology laboratory
    • Equipment rentals
    • Thermal mapping
    • Equipment Commissioning (Factory and Site Acceptance Tests)
  • Engineering
    • Engineering Support – Drawings / SOPs / Redline P&IDs / URS development
    • Support Preventative Maintenance and Product Specifications 
    • Provide Certification Programs for Capital Projects and Lifecycle Management for Process, Facility, and Utility Systems
    • Technical Writing - SOPs / LOTO Procedures / Global Harmonization / Risk Assessments / Training documentation creation and performing training
  • Project Management (Fractional or Full time)
    • Planning and Managing complex capital projects
    • Commissioning Qualification Validation projects
    • Construction Punchlist
    • And more
Member benefits, exclusive discounts, and more.



    About PSC Biotech®

    PSC Biotech® act as a seamless extension of your company to assist you in producing the highest quality products. PSC® has supported over 1000 clients in +35 countries worldwide, representing one of the world’s largest, specialty, life sciences consultancy firms.

    Specializing in quality and validation, PSC Biotech® offers services in Commissioning, Qualification and Validation (CQV) Planning, Regulatory Affairs, Quality Assurance, Audits and Gap Analysis, and more. Work with PSC Biotech® for tailored and cost-efficient project assistance for all your quality, systems, and regulatory needs.

    PSC Resources

    How can the BIO Business Solutions Customer Success Team Help?
    Tamy Dalal
    Tamy Dalal
    202.962.6635 • General Inquires
    Neil Lynch
    Neil Lynch
    202.365.6745 • Western US
    Jim Seymour
    Jim Seymour
    845.239.3325 • Eastern US