About us

Avendium is a specialized consulting firm that helps life science companies navigate complex regulatory requirements and build scalable, compliant quality systems. We provide expert-led support in quality assurance, regulatory affairs, validation, and auditing to accelerate compliance and enable innovation

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Our Mission

Our mission is to deliver quality and regulatory excellence; ensuring compliance, advancing patient safety, and creating lasting value for our clients.

Two healthcare professionals target a goal of quality assurance with precision.
Quality Assurance: Three scientists in a lab conducting tests, analyzing samples, taking notes.. Qu

Customers We Serve

  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Clinical Research Organizations (CRO)
  • Clinical Laboratories
  • IVD Manufacturers
  • Pre-Clinical

Meet Our Leadership Team

The visionary leaders driving our mission forward and pushing the boundaries of what’s possible.

Lars Mouritsen

Lars Mouritsen

President & CEO

Lars Mouritsen is the Founder and CEO of Avendium, where he brings over 25 years of experience in quality assurance, regulatory affairs, laboratory operations, and clinical development across the pharmaceutical, biotechnology, and diagnostics industries. A certified Diplomate in Laboratory Management (ASCP), Lars has led global GxP vendor qualification programs, directed regulatory strategies for oncology clinical trials, and built quality systems aligned with CAP, CLIA, ISO standards, and FDA 510(k) submissions.

Prior to founding Avendium, Lars held leadership roles at Sumitomo Pharma Oncology, Tolero Pharmaceuticals, and Sorenson Genomics, where he oversaw cross-functional programs in biomarker development, companion diagnostics, and laboratory innovation. He is recognized for his strategic, risk-based approach to compliance and his ability to design scalable systems that meet both regulatory requirements and business goals.

Lars holds a Bachelor of Science in Biology from the University of Utah and maintains certifications in immunology, molecular biology, quality systems, and Six Sigma. His leadership drives Avendium’s mission to provide pragmatic, expert-driven quality and regulatory solutions that enable life science companies to grow with confidence.

Tanner Mouritsen, MBA

Tanner Mouritsen, MBA

Managing Partner

Tanner leads business development, operations, and overall strategic direction. With a background in mechanical engineering and an MBA, Tanner brings a strong foundation in both technical problem-solving and business execution.

He works closely with life science clients to develop and implement regulatory and quality strategies that support long-term growth and market access. Tanner’s leadership ensures that Avendium remains agile, client-focused, and results-driven. His ability to bridge technical detail with operational efficiency allows the firm to deliver tailored, high-impact solutions across the pharmaceutical, biotech, medical device, and diagnostics sectors.

Regan RN, BSN

Regan RN, BSN

Marketing & Operations Coordinator

Regan supports branding, outreach, and internal operations. A licensed Registered Nurse with a Bachelor of Science in Nursing, Regan brings clinical insight, a passion for science, and a keen eye for strategic communication. She plays a vital role in ensuring Avendium’s messaging, marketing, and internal workflows reflect the firm’s commitment to excellence. Regan is known for her adaptability and dedication to supporting the team wherever needed to advance client outcomes and company growth.

Meet Our Team Of Experts

Raymond Jessen, MPH, MHSA

Raymond Jessen, MPH, MHSA

Executive Consultant, Regulatory Affairs

Ray is a senior executive with over 25 years of experience leading regulatory, quality, and operational functions across the medical device, pharmaceutical, biologics, transplant, and clinical sectors. He specializes in global regulatory strategy, continuous improvement, and patient safety initiatives. Ray has successfully led interactions with regulatory authorities across the U.S., EU, PMDA, SFDA, and other international markets. His leadership is defined by strategic vision, cross-functional collaboration, and a commitment to driving compliant and scalable quality systems that align with business and regulatory goals. 

Jon Ahlstrom, PhD

Jon Ahlstrom, PhD

Fractional Laboratory Director & System Validation Consultant

Dr. Ahlstrom is an accomplished clinical and regulatory expert with 11 years of GMP cell therapy manufacturing experience and over 15 years of analytical method development in molecular biology, immunology, and toxicology. He holds a Ph.D. in Cell & Developmental Biology from UC Davis and is board-certified in Molecular Diagnostics (HCLD/TS, ABB) and as an MB (ASCP). He has built and validated multiple clinical labs, led LDT and LIMS validations, and successfully supported CLIA inspections. Dr. Ahlstrom is known for his ability to design and implement robust QMS frameworks that ensure regulatory readiness and operational efficiency.

Sourav Banerjee

Sourav Banerjee

Executive Consultant, Regulatory Affairs & Quality Assurance - AI Systems

Neil is a seasoned QA leader with over 26 years of experience in the pharmaceutical, CRO, and clinical software industries. He has held senior roles including Director and VP of Quality, leading global quality initiatives and regulatory compliance efforts. Neil has implemented end-to-end Quality Management Systems, prepared companies for regulatory inspections, and conducted mock audits for GxP environments. He has presented at DIA conferences, contributed to industry guidance on data integrity, and trained international regulatory authorities. His expertise spans validation, regulatory strategy, inspection readiness, and cross-functional quality leadership across complex, fast-paced organizations. 

Scott Penoyer

Scott Penoyer

Executive Consultant, GMP/CMC Quality

Scott is a senior GMP and CMC Quality Assurance leader with over 20 years of experience in the pharmaceutical and biopharmaceutical industries. He has led quality programs across clinical and commercial manufacturing for small molecule APIs, biologics, and advanced therapies. Scott’s expertise includes regulatory compliance, quality systems, and vendor oversight, with experience managing global manufacturing partners in the U.S., Japan, and Europe. He has held leadership roles at companies such as Sumitomo Pharma, Biogen, and Wyeth Biotech. Scott holds a B.A. in Biology from Lycoming College and completed graduate studies in Microbiology and Molecular Biology at Bucknell University.

Breeann Bryan

Breeann Bryan

Senior Consultant, Quality Management Systems

Breeann is a quality and operations leader with experience across biotechnology, nutraceuticals, and pharmaceuticals. She began her career in a high-throughput DNA testing lab and advanced to laboratory manager and safety officer. A Lean Six Sigma Black Belt, she specializes in root cause analysis, KPI monitoring, and continuous improvement in regulated environments (ISO 17025, CAP/CLIA, AABB, NYSDOH). Breeann supports companies in building and implementing Quality Management Systems aligned with ISO 9001 and ISO 13485, guiding them through certification readiness and successful audits with notified and certifying bodies.

Leah Jones

Leah Jones

Lead Auditor & Quality Consultant

With 20 years of experience in Quality within the medical device industry, Leah specializes in ISO audits, supplier audits, and FDA remediation projects for organizations operating under ISO 13485, ISO 9001, and ISO 22716. She has deep expertise in preparing companies for certification and surveillance audits, and extensive experience working with Class I, II, and III medical devices. She holds a master’s degree in Organizational Leadership with a focus in organizational development consulting, is a Certified Quality Auditor (CQA), and a Six Sigma Yellow Belt (CSSYB). A published author in Quality Progress and blog contributor to MasterControl, she brings both regulatory insight and strategic communication to every project.

Timothy Dore

Timothy Dore

Tim Dore is a drug discovery specialist with expertise in strategy and project management, molecular design, chemical library design, hit finding through virtual and biological screening, and hit through lead optimization. He is deeply experienced leading international, multidisciplinary research teams to conduct cutting-edge research in medicinal chemistry and chemical biology. He has a proven track record in conceiving, launching, and building new initiatives and driving drug discovery. He has worked with multiple therapeutic modalities and disease areas and created the chemistry to drive the discovery platforms at several biotech start-up companies. Prior to working in the biotechnology and pharmaceutical industry, Dr. Dore was on the faculty at the University of Georgia and New York University Abu Dhabi and a visiting professor at Kyoto University. He holds a BS in chemistry from the University of North Carolina-Chapel Hill and a PhD in chemistry from Stanford University. He completed postdoctoral training with Nobel Laureate Roger Y. Tsien at the Howard Hughes Medical Institute and the University of California, San Diego.

Trusted by Our Partners:
Master Control
QA Connect Management Consulting LLC
ELR Lab Services LLC
BioUtah
BioHive

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