Solutions in Life Sciences
Upon acquiring BioStaff Solutions in November of 2018, the team at PTS Advance now deliver expertise and solutions to our customers through two distinct practice groups:
- With over two decades of experience working with leading Pharmaceutical, Medical Device, Biotechnology and Clinical Research Organisations, we deliver staffing, pre-identified candidate management, and full-scope consulting solutions. Our team has been responsible for deploying over 800 consultants in the US, and assisting with numerous international assignments on business trips and full relocation.
Compliance & Manufacturing
- Our experts bring more than a combined 120 years of experience and are readily deployable to partner with your quality, validation and compliance teams. Learn more about how we can help to design and deliver work programs to shape a sustainable compliance environment.
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
- Clincal Project Manager
- Study Manager
- Clinical Research Associate / Coordinator
- Scientific Writer
- Medical Writer
- Technical Writer
Compliance & Manufacturing
Our Subject Matter Experts are well-versed in latest FDA regulations, industry guidance and best practices across the GxP within the Medical Device, Biotechnology and Pharmaceutical industries.
Learn how our industry experts can help you to 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.