Solutions in Life Sciences
The team at PTS Advance has been successfully supporting regulated environments for over two decades.
Quality Safety Compliance
It’s in our DNA. Our Subject Matter Experts are well-versed in latest FDA regulations, industry guidance and best practices across the GxP within the Medical Device, Biotech and Pharmaceutical industries.
The global regulatory landscape changes rapidly. Learn how our industry experts can help you shape a sustainable compliance environment and design meaningful quality systems with the proper controls in place to meet your short and long-term business objectives.
Inspection Readiness and Support teams
Periodic inspections are a necessary challenge while navigating within the complex regulatory requirements. Our former FDA consultants can help you prepare to meet those requirements while still allowing your company to focus on its core objectives of healthcare innovation.
483/Warning Letter/Consent Decree Remediation
When you’re faced with a corporate-wide response, our team of experienced quality and validation consultants are readily deployable to facilities across the globe to immediately address critical areas requiring remediation.
Quality Management Systems
Creating and maintaining a culture of quality has never been more important. Our services cover the full range of quality systems initiatives within Quality Systems Regulations, ISO 13485 & 14971, current Good Manufacturing Practices (cGMP), current Good Clinical Practices (cGCP), Medical Device Directives (MDDs) and Reporting (MDRs), Complaints, Corrective Action/Preventive Action (CAPAs), Adverse Events (AE), SOP development, Labeling consistency and accuracy, auditing and validation.
We offer the full spectrum of services to our customers to ensure your processes, software, equipment, and facilities are appropriately qualified and that regulatory requirements are interpreted appropriately.
Areas of Expertise
- Computer Systems Validation (CSV)
- Laboratory Information Management Systems (LIMS)
- Change Management Systems (CMS)
- Distributed Control Systems (DCS)
- Supervisory Control and Data Acquisition Systems (SCADA)
- Building Management Systems (BMS)
- Programmable Logic Controllers (PLCs)
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP)
- Facilities and Utilities Validation
- Customized IQ/OQ/PQ development/execution
- Utilities – HVAC, compressed air, water systems
- Equipment commissioning/qualification
- Temperature and environmental mapping
Cleaning and Manufacturing Equipment Validation
- Aseptic/sterile processing
- Filling and mixing equipment
- Washers and autoclaves, CIP/SIP
- API manufacturing
- Water for injection systems
- Laboratory testing equipment