Our industry-leading compliance subject matter experts combine their technical and operational expertise in the areas of design, construction, commissioning, qualification, and validation to produce fully operational and compliant commercial operations.
By working on technically complex projects that span across geographic regions, industry sectors, and facility types, we have built an unmatched global regulatory understanding that allows us to provide our clients with effective and efficient regulatory decision making.
IPS Offers a Comprehensive Approach
With over 30 years of hands-on experience, IPS offers a comprehensive approach to understanding the regulations and validating within the CQV life cycle to ensure the consistency and quality of the manufactured product.
Our team of experts offers practical understanding and scientifically-based methodologies for risk- and science-based investigations, audits, remediation and quality system development services to help achieve your project goals and business objectives.
Improving Operations & Minimizing Costs
Our team focuses on increasing the efficiencies and improving cost and schedule performance of asset delivery and life cycle operations, from both a consulting perceptive and on the owner’s side. Our application of industry accepted project management approaches, lean concepts along with our collective experience allows for efficient projects as well providing a baseline for better cost of goods sold related to the life cycle areas impacted by CQV activities.
Commissioning, Qualification & Validation Specialties
Capital Projects and Existing FacilitiesLearn More
As a full service company, we simply understand and deliver projects extremely well from start to finish. We also support many clients with continuous improvement and ongoing qualification and validation activities in their new or existing facilities.
CGMP AuditsLearn More
As a global service provider, our compliance experts understand the increasingly rigorous global CGMP regulations and help our clients with conforming to regulatory expectations and requirements.
Our team of commissioning experts possess the experience and technical knowledge to execute the most complex, demanding projects and deliver a value-driven project.
Core C&Q ServicesLearn More
The core of our compliance services is in the support of vendor FATs/SATs and the preparation, execution, and report generation of IQ/OQ/PQ protocols.
CQV Program DevelopmentLearn More
We apply industry best practices to help our clients develop and implement lean efficient, effective, and fully compliant CQV programs.
Design Reviews and Risk AssessmentsLearn More
IPS has the expertise and tools to support a robust design review and/or risk assessment process.
Quality Management SystemsLearn More
IPS has a team of experienced quality professionals to support quality system audits and policy and procedure development.
Validation and Data Integrity ServicesLearn More
IPS has industry-recognized SMEs and dedicated teams that support process validation, cleaning validation, computer system validation (CSV) and data integrity, analytical methods validation, and environmental monitoring.
Customized Solutions for Cell & Gene Therapy
Featured Commissioning, Qualification & Validation Experts
Sr. Compliance Consultant/Sr. Vice President Compliance
Daniel G. Franklin, CxA
Manager, Compliance Services
Joanne Meloro, ASQ CQA
Director, Strategic Initiatives
Director of Aseptic Technologies - EMEA
Anthony J. Relvas, LEED AP
PA Regional Manager, Compliance
Mark E. Rezac, PE
Director, Compliance Services
NJ Regional Director, Compliance Services
Victor Singh, CxA, LEED AP
Sr. Director, Validation Services
Sr. Director, CQV Operations