Quality & Compliance

Agile Compliance Solutions for Efficient Product Development and Audit Readiness

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ATI Life Science Staffing

An Industry Leader in Quality & Compliance

In the distinct paths of medical device and diagnostics development, ATI Life Science Staffing stands out with a dedicated team of experts focused exclusively on these sectors. Our professionals understand the intricacies of bringing these products to market, whether you are embarking on developing your first product or are an established entity in the device or diagnostics industry. ATI Life Science Staffing tailors solutions to expedite your market entry effectively and efficiently.

Consulting Services

ATI Life Science Staffing’s Quality and Compliance Team offers consulting services tailored to the unique challenges in the healthcare sector. We provide access to industry experts who can answer a range of questions and offer solutions. Our team, with extensive experience across various healthcare facets, delivers compliant and efficient solutions.

Computer System Validation

ATI Life Science Staffing’s validation experts utilize cutting-edge risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques. Our goal is to ensure that your systems are inspection-ready for regulatory bodies like the FDA, EMA, and MHRA. Our expertise spans pharmaceuticals, biotechnology, medical devices, clinical research, and software industries, encompassing:

  • Cloud-based applications (SaaS and PaaS)
  • Configured Off-the-Shelf (COTS) applications
  • On-premise and cloud-based infrastructure (IaaS)
  • Covering initial, retrospective, and ongoing validation for software updates

Part 11 and Annex 11 Compliance

Adhering to FDA 21 CFR Part 11 and EU Annex 11 is crucial in our industry. ATI Life Science Staffing has the necessary expertise to prepare your systems, procedures, validation documents, and staff for compliance with these regulations.

Data Integrity

Data integrity is paramount for patient safety. Our experts apply the ALCOA principles to real-world scenarios, minimizing data integrity risks through system remediation, policy, procedure enhancements, and data governance programs.

Compliance

At ATI Life Science Staffing, we excel in addressing complex compliance challenges. Our experienced consultants integrate seamlessly with your team, identifying potential risks and developing mitigation strategies. We collaborate closely with you throughout the product lifecycle, from early development to commercialization, ensuring regulatory compliance and operational excellence.

Inspection Readiness and GxP Audits

Our specialists, including former regulatory agency inspectors, conduct mock inspections, internal audits, vendor and supplier audits, and gap assessments. We provide comprehensive support for pre-approval inspections (PAI) and ensure continuous alignment with evolving regulations and standards.

Quality Investigations and CAPA Support

ATI Life Science Staffing offers expert investigation and CAPA support within your quality system, or we can assist in developing and optimizing your program. Our team, rich in industry experience, defends investigation and CAPA systems to regulatory bodies, ensuring efficient and compliant operations.

EU and UK Batch Release through Diati’s MIA License

Navigating EU and UK regulations can be challenging. ATI Life Science Staffing holds both EU and UK MIAs, assisting clients in overcoming complexities and creating tailored strategies for market entry. Our Qualified Person services under our MIA licenses expedite product release, ensuring quick and flexible market access.

Qualified Person (QP), Responsible Person/Responsible Person Import (RP/RPi)

Our quality assurance professionals augment your internal capabilities, ensuring products are consistent and safe. ATI Life Science Staffing’s QP consultants, well-versed in GMP processes, ensure compliant manufacturing and/or importation of products in the EU and UK markets.

Remediation

ATI Life Science Staffing offers remediation services across pharmaceutical, biotech, medical device, and compounding pharmacy operations. Our team organizes and communicates the requirements of the remediation effort, partnering with you to build your remediation plan and implement efforts to maintain efficient and compliant operations.

Quality Management Systems (QMS) Development and Optimization

We work with organizations of all sizes to design, implement, or remediate QMS based on business needs and regulatory expectations. Our professionals ensure that your QMS is appropriate for your product’s development phase, establishes regulatory compliance, and is right-sized for your organization.

Program & Project Management

ATI Life Science Staffing’s Project Management offering ensures that the right resource or solution is applied to your projects. Our project managers have successfully implemented complex projects and transformational initiatives, blending subject matter expertise and project design to meet your specific needs.

R&D Process Optimization & Organizational Change Management (OCM)

We collaborate to optimize your processes using industry-leading techniques, ensuring success through integrated OCM processes. This approach ensures that changes are sustained post-project completion.

Post-Merger Integration

ATI Life Science Staffing’s expertise in Quality Assurance and Post-Merger Integration ensures successful integration execution, addressing the complexities of maintaining compliance across quality systems while managing costs and process redundancies.

Technology Transfer

Our Gated Technology Transfer methodology is designed to meet your production and technology demands efficiently and compliantly. We have a proven track record of successfully navigating the complexities of technology transfers.

Vendor Selection & Management Services

ATI Life Science Staffing’s services streamline vendor selection and management, saving you time and ensuring decisions are structured and data-driven. We manage the entire process, from identification to ongoing governance and audit processes.

Commissioning, Qualification and Validation

Our experts provide comprehensive process validation services for pharmaceuticals and biotech, ensuring your manufacturing processes maintain quality and compliance throughout the product lifecycle.

Medical Device

At ATI Life Science Staffing, we recognize that the journey for medical devices and diagnostics differs fundamentally from drug development. This understanding has driven us to assemble a dedicated team of specialists focused solely on supporting clients in the device and diagnostics sectors. Our experts are well-versed in the nuances of bringing these products to market, offering guidance in designing efficient and compliant trials that align with your specific objectives.

Navigating the Regulatory Landscape: Our team is adept at steering clients through the regulatory challenges associated with medical devices and diagnostics in both the US and EU. This expertise is crucial for successfully managing the complex regulatory environment and ensuring compliance across different markets.

Quality Systems

Quality Management Systems (QMS) form the cornerstone for medical device manufacturers and their affiliates, enabling compliant operations and solid business management foundations. ATI Life Science Staffing works closely with companies of all sizes to design, implement, or enhance QMS, ensuring they are tailored to the company’s phase of product development, type of product, and organizational scope. Our approach focuses on:

  • Developing a QMS that’s “right-sized” for your company, balancing regulatory compliance with operational efficiency.
  • Laying the groundwork for ongoing regulatory adherence and continuous improvement.
  • Addressing the regulatory demands of all intended markets, ensuring a comprehensive compliance strategy.

Our industry-leading experts, versed in complex regulatory elements, assist in guiding your team through the regulatory maze specific to your product, delivering comprehensive training and support throughout the audit and approval processes.

Remediation

ATI Life Science Staffing’s extensive experience with ISO 13485, 21 CFR part 820, and other global regulatory requirements positions us uniquely to support remediation activities throughout the medical device and diagnostics product lifecycle. Our team is equipped to handle both proactive projects, like transitioning to new regulations (MDR and IVDR), and reactive scenarios, such as addressing findings from regulatory bodies. We provide critical support in risk management, design control, and technical documentation, ensuring your products meet global compliance standards.

Program and Project Management Support

Our project management experts bring their deep experience in the medical device and diagnostics fields to support projects at every lifecycle stage, from early feasibility through to post-market support. Whether establishing a new project, providing resources for ongoing initiatives, or realigning existing projects facing challenges, ATI Life Science Staffing offers tailored project management solutions.

Our unique, focused workshop, proven in over 250 instances, streamlines project alignment, chartering, resourcing, and scheduling. This efficient process is particularly effective for launching new projects or recalibrating existing ones to address shifts in scope or overcome critical hurdles.

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Elevate your staffing experience with ATI Life Science Staffing. Contact us now to experience excellence in Life Sciences staffing, where precision meets passion, and success is the ultimate destination.

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