Our services

  • Product Portfolio Management

  • Mentorship and Leadership Development

  • Innovation Integration

  • Cultural Transformation

  • Inspection Readiness and Hosting

  • Regulatory Expertise

  • Implementation and Improvement of Quality Management Systems

  • Global Quality Strategy

  • Regulatory Compliance

  • Operational Excellence

  • Quality Improvement

  • Cross-Functional Leadership

Global Quality Strategy and Operations:

Strategic leadership in global quality strategy and operations across pharmaceutical, biotech, and medical device industries.

Expertise in orchestrating successful regulatory inspections to ensure compliance with FDA, EMA (various EU agencies), MHRA, Health Canada, PMDA, TGA, Anvisa, and other global agencies.

Proficiency in Achieving ISO Certifications and MDSAP from Certification/Accreditation Bodies

Regulatory Compliance and Excellence:

Proven track record in achieving regulatory milestones, including Investigational New Drug Application, in record time.

Leading cross-functional teams to establish risk-based quality systems, facilitating fast-track pathways for critical projects and unmet medical needs.

gray concrete wall inside building
gray concrete wall inside building
people walking on street near building during daytime
people walking on street near building during daytime
worm's-eye view photography of concrete building
worm's-eye view photography of concrete building
Quality Improvement and Operational Excellence:

Driving significant quality improvement, with a focus on GxP compliance, resulting in operational efficiency gains.

Optimizing quality systems, implementing harmonized electronic systems, and leading successful expansions within budget and timelines.

Expertise Across Diverse Product Portfolios:

Mastery in managing diverse product portfolios including small/large molecules, sterile and non-sterile, combination products, medical devices and more.

Oversight of GLP studies, GCP Clinical oversight, GDP for global distribution systems and GMP (all phases) for drugs, medical devices, and combination products.

Leadership Development and Cultural Transformation:

Mentorship-driven servant leadership style focused on emotional intelligence and fostering continuous improvement.

Serving as an instrumental resource in maintaining stellar inspection histories, managing M&A deals, and executing successful change management and harmonization across multinational facilities.

person holding medicine pills
person holding medicine pills
white concrete building during daytime
white concrete building during daytime
A curved facade covered in white latticework
A curved facade covered in white latticework
Innovation and Technology Integration:

Commitment to leveraging cutting-edge technologies for operational efficiencies and ensuring regulatory compliance.

Expertise in navigating complex regulatory landscapes and driving transformative change within organizations.

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