Our Network of Consultants

A PhD consultant in the biotechnology and life sciences industry with over 17 years of experience working internationally. Specializing in customer insights, market-driven product development and strategic marketing, with expertise in genomic medicine, gene therapy, cell therapy, nanomedicine, NGS, molecular diagnostics, oncology, and more. Held leadership positions in biotech and life sciences companies in Canada, US and UK, including Abcam, STEMCELL Technologies, Thermo Fisher Scientific, Cytiva/Danaher.

I have a a D.Phil. in Biochemistry from the University of Oxford with first author publication in Nature Immunology; an MSc from University of Toronto and a BSc (Honours) from University of British Columbia.

Consulting Services include:
Voice of Customer/Customer Insights
Market Driven Product Requirements
Value Propositions and Product Positioning
Product-Market fit
Competitor Landscape Assessments
Pricing Strategies
Go to Market Strategies

With over a decade's experience in Life Sciences, Biotechnology Commercialization and Law, I have developed a broad scope of skills in various fields, ranging from sales and marketing, to regulatory and logistic affairs. During my time as business developer, I assisted companies in establishing global distribution networks, raised global awareness through marketing campaigns, and increased sales revenue three-fold within 18 months. I have substantial experience in biotech commercialization and have successfully overseen the commercial release of more than 80 products into the global market.

I specialize in assisting companies to develop and expand their business in South Africa and other African countries. This process entails the development and implementation of a commercial strategy that is tailored for the specific territory of interest, as well as the establishment of customer and distributor networks, and guidance as to regulatory compliance and logistic considerations. I have an aptitude for relationship building, strategic planning and target customer profiling, which forms the foundation of my business development capabilities.

With more than 10 years of R&D experience in biochemistry and infection biology, I am a Senior Scientist for Surface Chemistry in Biotechnology at e-Proteins, the world leader in avidin derivatives production. I have been applying my expertise and skills to develop innovative binding protein solutions for diagnostic, biotech, and pharma industries, addressing the main challenges of streptavidin-based applications.

As a team leader and co-founder of Sapoto, I have also been managing and coordinating a team of 30 employees, integrating external service providers, and overseeing the quality management activities for other test centers. I hold the credentials of QMB Manager and Internal Auditor, which enable me to ensure compliance with GMP, GLP, and GCP standards. My mission is to contribute to the advancement of biotechnology and improve the quality and reliability of binding protein products.

Innovator with extensive experience and a proven track record of developing successful corporate strategies that increase revenues in the Life Sciences industry. Creative visionary and change agent who identifies growth markets, business drivers and builds collaborative global and cross-functional relationships. Recognized for combining transformational business strategies with supporting business cases, operating plans, budgets, and programs.
EXPERTISE
Strategic Planning | M&A | Financial Analysis | Partnerships and IVs | Market Assessments | Negotiation | Deal Structuring | Due Diligence
APPLICATIONS
Flow cytometry, antibodies, reagents, dyes, instruments ( sorters and analyzers)

Our consultants have extensive experience of working within start-up and small company environments and have developed their skills and expertise across a variety of disciplines within the IVD industry including, quality assurance, regulatory affairs, design and development, innovation, manufacturing and Notified Body lead auditing.

Our credentials include the preparation and management of international regulatory submissions, QMS implementation and maintenance in compliance with global regulatory requirements and the successful development and commercialisation of IVD products within entrepreneurial settings.

Noteworthy former senior leadership roles within pioneering IVD companies include Head of Quality Assurance and Regulatory Affairs, Chief Technology Officer, Head of Site and Director of Innovation and New Technologies.

We offer a range of pragmatic, flexible and customised consulting and training services covering regulatory, quality, product development and innovation to support our clients from product concept to commercialisation and beyond. These include:
• Person Responsible for Regulatory Compliance (PRCC).
• Product classification and regulatory strategy.
• Performance evaluation planning and reporting, including scientific validity, analytical performance and clinical performance.
• Risk management (ISO 14971).
• Preparation of regulatory submissions in compliance with the UK MDR, EU IVDR and other global regulations.
• Technical documentation review and remediation.
• Review of marketing, product packaging, labelling and instructions for use to ensure compliance with global requirements.
• Post-market surveillance and vigilance guidance.
• Gap analysis.
• Identification of applicable standards.
• QMS implementation, remediation and maintenance in conformity with ISO 13485, MDSAP and other global requirements.
• Quality planning guidance, including quality objectives and management of changes to the QMS.
• Quality impact assessment of design and development activities.
• Manufacturing and QC documentation guidance.
• Supplier control, including the control of critical outsourced processes.
• Equipment and QMS software validation guidance.
• Control of nonconformities, including root cause analysis, corrective action and preventive action.
• Management review.
• Internal auditing and gap analysis.
• Innovation input to new product concepts.
• Evaluation of novel technologies for IVD applications.

30 years experience building Life Science businesses. Involved in the set up and growth of 15+ various Life Science businesses from diagnostic, software and biotechnology based companies. Advise on BD deals and M&A, having been involved in numerous large deals and 6 exits both on the buy and sell side. Worked with large corporate's such as Unilever plc and Alere Inc, and sat on Boards of various SMEs like; Cumulus Oncology, DxCover and Innova Biosciences.
Experience working with Boards and business owners with change management and building successful businesses with a wide network across the Life Science sector plus links to investment and financing.

Specialities: Life Science Consultancy, working with Boards and scaling & exiting businesses.