If you’re here, chances are you’re considering, or already actively searching for, a knowledgeable life sciences consultant to help pave the way for your organization’s future growth.
Maybe you need support achieving ISO 13485 certification, obtaining your CE mark, or overcoming challenges with international market access for your medical device.
Perhaps you need guidance navigating CSV, strengthening your GDP compliance, or ambitiously implementing AI/ML and automation in your quality operations.
Whatever the reason, life sciences consulting can bring enormous value to your organization, helping you save time, reduce risk, and even cut costs in the long run. After all, it’s much easier to follow the lead of someone who has successfully overcome these regulatory hurdles hundreds of times before.
But with so many life sciences consultants out there, all highlighting impressive certifications and experience, how do you know whom to trust?
To help you find the support you need, we’ve compiled a list of the best life sciences consultants, all of whom we’ve personally collaborated with over the past year, whether through our Smart Quality Summit 2025 or our online webinars.
Whatever your specific need, we’re confident you’ll find a consultant or subject matter expert on this list who can help. Here's our list in no particular order!
Lesley Worthington has 20 years of quality and regulatory experience, coupled with university degrees in psychology and law. Her background includes thousands of hours of teaching and coaching.
How Lesley can help you:
As a trained executive coach, Lesley provides professional development support and guidance with a focus on communication skills and relationship management, equipping her clients with essential skills, techniques, and insights.
Her approach boosts their confidence, enhances their communication abilities, and empowers them to make a positive impact within their organizations.
She’s the go-to person for anybody who feels like their people and communications skills might be standing in their way, especially frustrated quality professionals who are frustrated to get everyone on board with quality!
Karandeep Badwal is a UK-based regulatory consultant with a background in regulatory and clinical, specialising in software and AI-driven MedTech.
How Karandeep helps you:
As a seasoned regulatory and clinical professional, he supports startups in the EU and US with CE marking, FDA submissions, and quality system implementation.
Through QRA Medical, he helps innovative companies navigate complex regulatory pathways with clarity and confidence. He is also the host of the MedTech Podcast and serves as a judge for MedTech Innovator and Springboard Enterprises.
Kurt In Albon is a quality expert with deep experience at the intersection of pharmaceutical quality and information technology. He spent over two decades at Lonza, one of the world’s largest pharma CDMOs, where he held roles across IT, quality assurance, quality control, and management.
How Kurt can help you:
Drawing on his cross-functional experience, Kurt supports organizations in building robust quality data governance frameworks and aligning IT systems with regulatory and quality requirements.
With an MSc in Pharmaceutical Validation Technology, Kurt shows his deep commitment to data quality, patient safety, and effective governance across computerized systems in healthcare and pharma with every client that he works with.
If you need a system that ensures data integrity, compliance, and operational efficiency, he's your guy!
Martin King is a Swiss-based consultant with over 30 years of experience in medical devices, in vitro diagnostics (IVD), and pharmaceuticals. His career began in 1979 and includes early work on active wearable devices,
How Martin can help you:
Martin supports companies in achieving successful regulatory submissions across a wide range of markets, drawing on experience that spans six continents.
As a trained ISO 13485:2016 Lead Auditor, he helps organizations align with key standards and regulations, including 21 CFR 820, ISO 13485, ISO 14971, and MDR 745/2017.
Martin is known for his hands-on approach, strong ethical standards, and ability to navigate complex regulatory environments, making him a trusted advisor to organizations worldwide.
Jennifer Mascioli-Tudor brings over 20 years of experience across the pharmaceutical and medical device industries, with a strong track record in implementing and optimizing quality systems within major healthcare organizations.
How Jennifer can help you:
As the Founder and CEO of JMT Compliance Consulting, Jennifer works closely with MedTech companies to strengthen their quality, business, and regulatory strategies.
She is a trusted partner for teams looking to build and improve compliant, scalable quality systems that align with both regulatory requirements and business goals.
In addition to her consulting work, Jennifer teaches regulatory affairs at UC San Diego, combining practical industry expertise with academic insight.
Ivan Perez Chamorro is the Founder and CEO of MedBoard, with a strong background spanning science, business, and the medical industry. He holds a BSc and MSc in Physics, as well as an MBA.
How Ivan can help you:
Ivan helps organizations streamline regulatory, clinical, and market intelligence processes through integrated, data-driven solutions.
With MedBoard, he enables teams to access up-to-date global data and leverage AI to improve research, compliance, and decision-making.
His approach empowers professionals to work more efficiently, reduce complexity, and focus on what truly matters, bringing better products to market faster.
Andrés Gola is a regulatory compliance consultant with over 15 years of experience in FDA-regulated environments. He holds a Master’s degree in Biomedical Engineering from the University of Miami, and is also RAC (Devices) certified by the Regulatory Affairs Professionals Society (RAPS).
How Andrés can help you:
Andrés supports organizations in achieving and maintaining compliance across FDA and EU regulatory frameworks, with a strong focus on quality systems and GMP environments, where he has extensive experience.
Having worked in quality-focused roles at multinational companies, including Johnson & Johnson and Becton Dickinson, both in the U.S. and Europe, he helps teams prepare for audits, strengthen processes, and address compliance gaps with confidence.
Peter Sebelius is a highly regarded trainer, consultant, and entrepreneur in the medical device industry. He is the founder of Medical Device HQ and a member of the Joint Working Group behind the latest versions of ISO 13485 and ISO 14971.
How Peter can help you:
Peter helps medical device companies understand and implement key regulatory standards, including ISO 13485 and ISO 14971, with clarity and confidence.
Through training and consulting, he supports teams in building compliant quality management systems and applying risk management principles effectively.
With extensive hands-on experience, Peter has been involved in the development of advanced medical technologies, including a mechanical chest compression device and an ex vivo lung perfusion system. This real-world experience enables him to help companies bridge the gap between theory and implementation, accelerating development while ensuring regulatory compliance.
Yves Dène is a senior computer systems validation (CSV) expert with over 25 years of experience in compliance across the life sciences industry. He began his career in the chemical and synthetic industry as an ISO 9000 and Quality Manager.
How Yves can help you:
Yves has worked with more than 50 organizations, from large pharmaceutical companies to startups.
He specializes in helping teams validate and maintain critical systems such as ERP, LIMS, clinical, and QMS platforms, ensuring they meet regulatory expectations and operate reliably.
If you're looking for a data integrity or CSV expert, he is sure to help you ensure compliance with computerized systems.
Dr. José Bohorquez is the President of CyberMed and Founder of Bold Type and holds a PhD in Electrical Engineering and Computer Science from MIT, with a minor in Business Administration from the MIT Sloan School of Management.
How José can help you:
José supports life sciences and MedTech organizations in developing secure, compliant software and cybersecurity strategies.
Having led R&D and security teams across IoT, biosensors, semiconductors, and health-tech, he has deep expertise at the intersection of cybersecurity and medical innovation.
With now over a decade of experience under his belt, he helps teams address complex security challenges in connected devices, ensuring alignment with regulatory expectations and industry best practices.
Kathy Walsh is a quality systems expert with over 25 years of experience across pharmaceutical, medical device, and biotech industries, as well as distribution, compounding, and clinical R&D organizations.
How Kathy can help you:
Kathy supports organizations in achieving GMP and ISO accreditation, as well as building and transforming Quality Management Systems tailored to their stage of growth.
She works with startups, scaling companies, and large enterprises to simplify and optimize QMS processes, making them more effective and easier to manage.
Kathy is known for her ability to simplify complex quality systems and drive impactful QMS and compliance projects.
Harsh Thakkar is the CEO and Founder of Qualtivate, a consultancy focused on enhancing quality management in the life sciences industry. He holds ASQ certifications in Quality Auditing and Quality / Organizational Excellence, as well as an M.S. in Regulatory Affairs and Quality Assurance and a B.Sc. in Pharmaceutical Sciences.
How Harsh can help you:
With over 15 years of experience, Harsh specializes in QMS strategy, GxP compliance, and building strong quality cultures across biopharma and MedTech organizations.
He supports organizations in designing and optimizing modern, scalable quality management systems and helps teams strengthen their quality culture while leveraging emerging technologies like AI and automation to improve efficiency and decision-making.
Additionally, through his consulting work and as host of the Life Sciences 360 podcast, he brings practical insights and forward-thinking perspectives to help companies stay ahead in an evolving regulatory and technological landscape.
Rodrigo Nasif is an author and entrepreneur specializing in the digital transformation of critical processes in the life sciences industry. With over 15 years of experience, he has been a key figure in driving innovation across the sector.
How Rodrigo can help you:
As General Director of Pharmware, Rodrigo has led the development of solutions that are reshaping how organizations manage and optimize their operations.
He helps teams improve efficiency, compliance, and decision-making by implementing solutions that streamline complex workflows.
His approach enables companies to adapt to an evolving digital landscape while maintaining high standards of quality and operational excellence.
Didier Griffoy is a scientist and quality leader with over 24 years of experience in the pharmaceutical and life sciences industry. He has held senior roles in quality and regulatory leadership, including Head of Quality and Regulatory Affairs at DiaSource Immunoassays.
How Didier can help you:
Didier is passionate about continuous improvement and innovative leadership models that strengthen quality culture across organizations. He supports organizations in building and evolving robust quality systems, with a strong focus on quality control and process improvement.
He helps teams develop effective quality strategies, optimize analytical methods, and implement sustainable improvements across operations.
His leadership-driven approach empowers organizations to foster a strong quality culture and drive long-term performance in complex, regulated environments.
Jeroen Leeman is a software validation expert and Lead Auditor with extensive experience in the pharmaceutical industry. He holds a Bachelor of Applied Science in Biomedical Technology and is certified as an ISO 9001 Lead Auditor.
How Jeroen can help you:
Jeroen has a strong background in validation, quality assurance, and compliance, with expertise in GMP, GLP, Six Sigma, and rapid prototyping. Jeroen currently works at QbD and also serves as a Lead Auditor at the European Medicines Verification Organisation (EMVO).
He supports life sciences organizations in validating computerized systems and ensuring compliance with GMP and regulatory requirements.
From helping teams to improve validation processes to preparing for audits and implementing efficient, compliant systems across their operations, he is all about delivering practical solutions.
Gonzalo Matías Barragán is a quality professional and qualified Lead Auditor with over 10 years of experience in quality assurance and quality control within multinational companies. He is a Food Science and Technology Engineer and previously served as Quality Manager at Unilever’s Foods division.
How Gonzalo can help you:
Gonzalo has conducted over 200 supplier audits and specializes in food safety management systems, pharmaceutical primary packaging materials, and quality management systems.
As part of Qualifyze, he conducts audits across packaging materials, medical devices, food, and cosmetic manufacturers, helping companies meet regulatory and quality standards.
He also contributes to the development of audit teams by training junior auditors, bringing a practical and structured approach to quality and compliance improvement.
Jordi Ferrando Benitez is a Quality Manager and auditor with over 10 years of experience in GxP audits across the life sciences industry. He is a chemist with a strong background in the manufacturing and quality management of APIs and excipients.
How Jordi can help you:
Jordi specializes in auditing manufacturers and distributors of APIs, excipients, finished dosage forms (FDFs), and starting materials, having conducted more than 200 audits throughout his career.
He supports organizations in ensuring compliance across complex supply chains through thorough GxP auditing and quality oversight.
As a Quality Manager at Qualifyze, he leads audit teams and oversees assessments of manufacturers and suppliers, helping companies meet regulatory and quality standards.
Chris Martin is a logistics and pharmaceutical supply chain expert with over 30 years of experience, including more than 17 years in pharma supply chain leadership. He is the founder and Managing Director of Christ GDP Pharma Ltd, specializing in Good Distribution Practice (GDP) and quality management across pharmaceutical supply chains.
How Chris can help you:
Chris supports organizations in achieving and maintaining GDP compliance across their end-to-end supply chains.
He helps teams identify regulatory gaps, enhance quality systems, and implement best practices in pharmaceutical distribution.
Chris is recognized for his ability to build a strong culture of quality while ensuring safe, compliant, and efficient product delivery.
Georg Digel is a quality professional with a diverse background spanning production, engineering, and global quality transformation. He began his career on the production line before earning a degree in biomedical engineering and moving into roles across consultancy, startups, and large corporations.
How Georg can help you:
Georg supports organizations in optimizing CAPA and non-conformance processes to improve quality performance and operational efficiency.
A key highlight of his career was leading a global quality harmonization initiative, aligning non-conformance (NC) and CAPA processes across more than 50 sites worldwide, earning recognition for its significant business impact.
He helps teams harmonize quality systems across sites, reduce complexity, and drive consistency in global operations.
Amy Wotawa is a global Quality Assurance leader with over 15 years of experience in regulated industries. She has also held leadership roles in global QA consulting, bringing a broad perspective on quality across organizations and systems.
How Amy can help you:
Amy is known for championing risk-based, human-centered approaches to GxP compliance, with deep expertise in vendor oversight, clinical trial quality, and strategic risk management.
She helps teams improve vendor oversight, enhance clinical trial quality, and embed effective risk management practices into their operations.
Her strategic and human-centered approach enables companies to build resilient, compliant quality systems that adapt to evolving regulatory demands.
Sandra Lopes Guerreiro is a quality and sustainability leader with over 20 years of experience driving excellence in regulated environments. She is passionate about building quality cultures that go beyond compliance and create long-term value for organizations.
How Sandra can help you:
Sandra has a strong background in Environmental, Health & Safety (EHS), quality systems, and corporate leadership, bringing a holistic and people-centric approach to quality management.
She helps teams build sustainable quality cultures, embedding best practices into daily operations and leadership approaches.
As a certified coach and mentor, she empowers professionals and organizations to move beyond compliance and make quality a core part of how they think and work.
Beat Keller is a regulatory affairs and quality management expert with extensive experience in medical device compliance and international market access.
How Beat can help you:
Beat is known for helping companies handle regulatory complexity while maintaining a clear path to market.
As the Founder of SMDC Swiss Medical Device Consulting GmbH, he supports manufacturers in navigating European and Swiss regulatory requirements and managing quality systems effectively.
Beat helps teams navigate complex regulatory frameworks, strengthen quality management systems, and ensure alignment with evolving requirements.
Choosing the right life sciences consultant for your needs
With so many experienced professionals across quality, regulatory, validation, and digital transformation, the challenge isn’t finding expertise, it’s finding the right expertise for your specific context.
Start by clearly defining your biggest need. Are you preparing for an audit, scaling your QMS, navigating a regulatory submission, or modernizing your systems? The more precise your challenge, the easier it becomes to identify a consultant whose experience directly aligns.
Next, look beyond credentials and focus on approach. Some consultants specialize in hands-on implementation, while others bring more strategic or coaching-driven support.
Finally, don’t underestimate the importance of communication and cultural fit. The best consultants help you build confidence, and leave your team stronger than before.
We wish you the best in finding the right consultant for you needs and if you’re looking for a digital QMS software, this is where Scilife can help.
