Solutions in Life Sciences
Our team of experts share over 80 years of experience supporting small and large scale projects in the Pharmaceutical, Medical Device, and Biotechnology industry segments.
Offering a complete range of resourcing solutions, from a singular placement through to the deployment of functional teams, PTS Advance partners with customers to design engagement models that meet core business objectives.
We operate as a cohesive team, while maintaining focus on two distinct practice areas; Clinical Solutions and Quality, Regulatory & Compliance Consulting.
We partner with your team to identify how to build, support and manage the expertise that is critical to your projects, across the below functional areas:
- SAS Programming
- Clinical Data Management
- EDC Programmer
- Inform Developer
- Metadata / RAVE Programmer
- Regulatory Affairs Specialist
- Quality Assurance Associate / Manager
- Case Coordinators
- Safety Associate / Scientist
- Medical Service Specialist
- Pharmacovigilance Physician
- Clinical Project Manager
- Study Manager
- Clinical Research Associate / Coordinator
- Scientific Writer
- Medical Writer
- Technical Writer
Quality, Regulatory & Compliance Consulting
Our Subject Matter Experts can support your Quality, Engineering, Project Management, Validation, Regulatory and Compliance functions to meet 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.