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Professional Services

Compliance and Audit Services

Achieve Regulatory Compliance & Quality Assurance Our team of experienced consultants is dedicated to helping you achieve regulatory compliance and quality assurance, while optimizing your business processes and performance. With a thorough understanding of biotech and pharmaceutical operations, and the regulatory challenges facing these industries, we have the experience, the skills, and the talent to […]

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FDA Regulatory Consulting

Advancing Therapeutics Through Pivotal Regulatory Affairs Approvals Maintain progress as your program reaches pivotal regulatory stages by engaging our experts to identify, prepare, and submit the appropriate materials to regulators. We provide expert insights on the best pathways forward to ensure adequate funding and technical support. With drug development being such an extensive, detail-oriented process,

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Product Stewardship

Achieve Product Stewardship Compliance Satisfy consumer, supplier, and regulatory expectations by maintaining product safety with our comprehensive support. With continuously increasing compliance requirements, you may face pressures to keep up with a growing, more complex workload. No matter the industry or phase of your responsibilities, we offer responsive, scalable capabilities across the product lifecycle to

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Hazard Communication

Effectively Manage Your Workplace Hazard Communication Program Ensure your workplace safety procedures meet Hazard Communication Standard (HCS) and Globally Harmonized System (GHS) requirements. Whether your needs range from strategic hazard communication programming to more tactical support, such as SDS authoring services, we customize our approach to address the specific challenges you face. Effectively managing and

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Facilities

Certified Facilities Validation Services & Equipment Qualification Maintain operations and minimize downtime with our facility validation and equipment qualification services. Our integrated facility qualification services include a range of support options to consolidate your partnerships and satisfy relevant quality standards. We understand your challenges and know that ongoing, compliant operations are critical to your business’

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Instruments

Responsive Laboratory Instrumentation & Equipment Services Ensure your lab instruments and equipment are working at peak performance with routine services. Our integrated facility services include a range of support options to help consolidate your partnerships and ensure your operations comply with relevant quality standards. By pairing decades of laboratory and CDMO operations experience, we understand

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Scientific Staff

Scientific Staffing Solutions to Drive Progress Expand your capacity with our qualified scientific experts who are committed to moving your project forward. Our insourcing services keep your lab running smoothly by curating scientific staffing solutions that meet your business needs and workflow requirements. From individual placements to a robust team, our staffing models are tailored

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Regulatory and Compliance

Navigate Stewardship, Regulatory Affairs & Compliance Requirements Ensure your business operations adhere to requirements and regulatory affairs expectations with our compliance services. We understand that constantly evolving expectations and business constraints make it challenging for you to keep up. We specialize in numerous industry sectors to provide relief where you need it most. Ready To

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Medical Device

Pace® Services for Medical Devices From finished products to facilities, we support the medical device industry with comprehensive on and off-site services. Like all manufacturers, medical device manufacturers need to ensure their air, water, and waste is free from contaminants, cleanrooms are certified and monitored, and lab equipment is maintained to operate at peak performance.

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Healthcare

Pace® Services for Healthcare Organizations Pace® testing and advisory services help healthcare organizations meet strict regulatory standards and ensure the health and safety of their patients and employees. Our expert team can identify potential risks and vulnerabilities from waterborne pathogens and other contaminants and share insights on mitigation best practices. Using the latest advancements in

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