Our staff combines fresh perspectives whith extensive experience to drive innovation in science and business models

Ofer has over 18 years of experience in the pharmaceutical, biotechnology, and medical device industries, specializing in compliance, quality assurance, validation, regulatory affairs, and cybersecurity. He holds a BSc in Biotechnology Engineering, an MSc in Environmental Engineering, and a PhD in Computer Science, along with certifications as an ISO Lead Auditor in ISO 9001:2015, ISO 13485:2016, and ISO 27001:2022. His expertise spans the pharmaceutical, biotechnology, medical device, and cosmetics sectors, with deep knowledge of quality assurance, validation, manufacturing processes, regulatory affairs, and the implementation of AI in systems. He has a proven track record in creating, implementing, and leading quality management systems, as well as providing training in these areas. His success includes leading inspections by the FDA, Health Canada, and other regulatory bodies, receiving an award for outstanding quality records, reducing regulatory penalties, and eliminating product launch errors. Known for his strategic vision, excellent management skills, and ability to prioritize tasks under tight deadlines, he has worked with major companies across North America, Europe, and Asia to improve processes, reduce costs, and establish interfaces between QA, R&D, regulatory affairs, and other departments.

As the Chief Operating Officer of the company, Noga brings a master's degree in clinical psychology and a strong skill set in managing daily operations. With a deep understanding of organizational behavior and interpersonal dynamics, she ensures seamless coordination across all departments, fostering collaboration and effective communication. Her expertise in overseeing operational workflows allows her to optimize resource allocation, manage client projects, and ensure the company consistently meets its goals and client expectations.

Known for her strategic thinking, she plays a key role in driving operational excellence, improving efficiency, and maintaining a positive, productive work environment.

With over 8 years of experience in the pharmaceutical and medical device industries, Charles has a strong focus on quality assurance, validation, research and development, and regulatory affairs. Holding a BSc in Biochemistry and a PhD in Cellular and Molecular Medicine, with a specialization in developmental signaling pathways, Charles has extensive management and consulting experience in global pharmaceutical, biologic, and medical device sectors. He has successfully led drug product development from conception through GMP manufacturing, managing multiple complex projects under accelerated timelines. Known for building and leading highly productive, multifunctional teams, he excels in adapting to new challenges and roles, with a strong collaborative approach to project development and management. His expertise includes team building, improving communication strategies, strategic planning, and exceptional problem-solving skills. With excellent oral and written communication abilities, he can synthesize complex scientific concepts and translate them into successful product and research program ideas.

Julien is an experienced technology consultant with over 12 years of engineering expertise, specializing in computer system validation (CSV), cybersecurity, and artificial intelligence. He offers tailored solutions to industries from all fields of work, leveraging his deep knowledge of AI, machine learning, data science, and forensic analysis to help clients meet regulatory requirements, optimize systems, and enhance data security.
Julien’s expertise in improving validation documentation, supporting audits, and streamlining processes to meet evolving regulatory demands can be instrumental for organizations in achieving compliance, strengthening cybersecurity frameworks, and leveraging cutting-edge technologies to meet business goals while maintaining a focus on quality, safety, and regulatory success.
In the field of cybersecurity, Julien offers specialized services to identify, analyze, and mitigate cybersecurity risks and vulnerabilities, ensuring the safety and reliability of computerized systems and medical devices. His expertise includes assessing emerging technologies, developing cybersecurity policies, and implementing measures to protect systems throughout their lifecycle. Julien also helps integrate AI and machine learning tools to enhance decision-making, improve operational efficiency, and address complex technical challenges.

Biochemistry Student (BSc), Concordia University.

Assisting with research, documentation, and data analysis to support client deliverables. Coordinating projects, maintaining compliance records, supporting in administrative tasks, and contributing to smooth operations.