PSCBiotech provides regulatory and compliance support in the development, manufacturing and distribution of healthcare products. BioMedSA members receive a 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
