Our emphasis lies in delivering added value, ensuring projects are timely, within budget, and surpass quality benchmarks. We strategize diligently and act decisively. In managing complex opportunities, we optimize outcomes.
We pinpoint deficiencies, formulate precise action blueprints, mobilize the most adept professionals from our network, and operate to go beyond the set targets.
OUR APPROACH: CPQ-KT
Compliance Management: We guide clients aiming to optimize efficiencies and achieve compliance excellence. Our robust network specializes in audits and compliance remediation, having supported both enforcement actions and proactive quality improvement projects worldwide.
Our professional network boasts expertise across the full spectrum of cGMP applications, from R&D to commercialization.
Project Management: We utilize advanced project management methodologies and insights to ensure projects are steered correctly in terms of execution, resource allocation, reporting, and budgetary control.
Quality Risk and Knowledge Management: Empowering customers on developing the Knowledge Management Approach to facilitate a Validated State of Control on Pharmaceutical Process throughout Life Cycle applying agencies expected approach and tools including Risk Management. Mentoring, coaching and technical skills enhancement.
Talent Management: Enhancing professional resources sourcing through our Network and Talent Management Platform. We manage SOW, Capital Project and Contingent Contractors.
OUR LEADERSHIP TEAM
Boasts over 35 years in the bio-pharmaceutical field, initially as a Scientist and later leading consulting ventures since 1993, focusing on compliance, project management, and validation. Overseen 3000+ resources, completed 10000+ projects, including 600 in validation and 150 in compliance for top pharma companies. Known for on-time, on-budget project completions. Co-authored PDA Technical Report #60 on Process Validation.
Is our VP of Operations, specializing in Data Informatics and Analytics. With a solid scientific foundation, he spearheads well-managed data solutions to address business challenges. Dr. Benítez excels in relational database queries, designing tools, and creating metrics and dashboards for data visualization and insights. He plays a pivotal role in translating business needs into actionable data strategies.
Is our Project Management Officer with 30 years in chemical engineering. Expert in expansion strategies, plant setups in Biotech and Pharma, and compliance management. An SME in Technology Transfer and C&Q, she's engaged with the ISPE C&Q Task Force.
Is an Industrial Engineer with deep expertise in Operations and Project Management within highly-regulated manufacturing settings, spanning FDA, DEA, ISO, and EMA standards. Proven in leading Validation Capital Projects, FDA remediations, and operation startups. He's adept at product lifecycle transfers, significantly reducing manufacturing deviations, and backlog cuts. A Lean Six Sigma advocate, he's well-versed in both US and international regulations and inspection support.
is a seasoned Quality & Regulatory Affairs Leader in the pharmaceutical sector. He specializes in remediation, global Quality Systems, and GMP compliance. Jason excels in Quality System strategies, corrective actions, and is a recognized SME in Quality Initiatives. He's a skilled communicator.
Microbiology, specializes in biologics development. Educated at the University of Maryland and North Carolina State, he merges scientific depth with strategic insight. Irwin excels in optimizing processes, bridging science and business, and enhancing efficiency. His mentorship and expertise continually boost organizational success.