Selected work — from lab to launch.

Challenge

A North American brand sought to launch a premium healthy aging supplement featuring a novel botanical ingredient sourced from Asia. The ingredient had limited regulatory precedent in Canada and required a market-ready formulation suitable for both Canadian and U.S. markets.

Our Role

• Ingredient technical assessment and supplier qualification
• Formulation development and optimization
• Stability protocol design
• Health Canada regulatory strategy
• U.S. dietary supplement compliance review
• Manufacturing technology transfer

Challenge

A specialty pharmaceutical company required transfer of a prescription topical product from an overseas manufacturing site to a North American contract manufacturer while maintaining product equivalency and regulatory compliance.

Our Role

• Better Contract Manufacturing Organization (CMO) structure, strategy and qualification
• Technical transfer coordination
• Process validation oversight
• Regulatory documentation support
• Risk management and timeline control

Challenge

An innovative startup developing a wearable physiological monitoring device sought regulatory and quality system guidance for market entry in Canada, the United States, and Europe. The company required clarity on device classification, applicable regulatory pathways, and submission-ready technical documentation.

Our Role

• Conducted medical device classification assessments for Canada, the United States, and Europe
• Performed a gap assessment of the existing quality management system against ISO 13485:2016 requirements and MDSAP considerations
• Developed a regulatory submission strategy for Health Canada Medical Device Licence (MDL) requirements, applicable U.S. FDA premarket pathways including 510(k) where appropriate, and European regulatory considerations
• Provided support for the organization and structure of submission-ready technical documentation
• Supported the development of risk management documentation aligned with ISO 14971 principles
• Coordinated planning support for verification and validation activities, including biocompatibility, electrical safety, EMC, software validation, and cybersecurity considerations, where applicable

Challenge

A cosmetic brand sought to develop a skin brightening serum for topical use containing multiple active ingredients while ensuring compliance across Canada, the United States, and Asia-Pacific markets.

Our Role

• Ingredient selection and compatibility assessment
• Formula design and optimization
• Stability and preservative efficacy planning
• Cosmetic regulatory review
• Supplier qualification

Challenge

A client developing a pet joint health supplement sought support in formulating a stable product and understanding regulatory requirements for commercialization in Canada and selected export markets. The project required alignment of formulation strategy with permissible ingredients, claim positioning, and quality expectations for animal health products.

Our Role

• Regulatory assessment of allowable ingredients and claim boundaries for pet health products
• Formulation advisory for joint health positioning (e.g., mobility and cartilage support category)
• Ingredient sourcing support and specification review
• Stability and quality documentation guidance
• Label and claim review aligned with applicable pet supplement regulations
• Manufacturing and scale-up technical transfer support

Challenge

An ingredient manufacturer developed a proprietary bioactive ingredient and required a pathway to commercial adoption by supplement and functional food brands.

Our Role

• Regulatory intelligence
• Safety dossier development
• Scientific literature review
• Commercial positioning
• Partner identification

Challenge

A supplement manufacturer received observations during a regulatory inspection and required immediate remediation to maintain operational continuity.

Our Role

• GMP gap assessment
• CAPA development
• SOP redesign
• Quality system implementation
• Staff training

Challenge

A multinational ingredient supplier sought to identify emerging opportunities in healthy aging, metabolic health, and beauty-from-within categories.

Our Role

• Market intelligence research
• Competitive landscape analysis
• Scientific trend evaluation
• Regulatory assessment
• Commercial strategy development

Challenge

A biotechnology company developed a high-purity longevity ingredient produced through proprietary fermentation technology. The ingredient had established sales in Asia but lacked commercial presence in North America, and the company faced challenges related to regulatory acceptance, safety documentation, claim positioning, and customer confidence in Canada and the United States.

Our Role

• Conducted a regulatory and technical assessment of the ingredient, including manufacturing process, source organism, safety profile, and existing regulatory precedents
• Reviewed scientific literature and available safety data to support North American market entry
• Evaluated competitive positioning and market opportunities within the dietary supplement sector
• Developed a regulatory commercialization strategy, including a Canadian NHP ingredient assessment pathway, U.S. dietary supplement positioning strategy, structure/function claim framework, and technical dossier and customer support documentation

Challenge

A supplier developed a liposomal glutathione ingredient targeting beauty-from-within and healthy aging applications. Early customer stability studies showed inconsistent potency results, creating uncertainty around product shelf life and commercial adoption.

Our Role

• Conducted a technical investigation into potential causes of potency loss, including glutathione degradation, liposome stability changes, analytical method variability, and packaging compatibility concerns
• Evaluated liposomal characteristics through particle size, zeta potential, and encapsulation efficiency testing
• Supported oxidative degradation assessment and stability protocol development
• Designed accelerated and real-time stability evaluation approaches
• Identified manufacturing process factors contributing to oxidation instability

Challenge

A functional ingredient company developed a standardized food-derived bioactive ingredient targeting attention, working memory, and mental fatigue support. Although preclinical data suggested cognitive benefits, the ingredient lacked controlled human clinical evidence needed for commercial differentiation and regulatory-compliant claims.

Our Role

• Designed a multi-domain cognitive clinical development strategy in collaboration with an academic research institute and experienced Principal Investigator (PI)
• Supported development of a randomized, double-blind, placebo-controlled clinical study design
• Evaluated cognitive performance using validated assessment tools
• Supported evaluation of brain activity through functional MRI (fMRI) during cognitive task performance
• Developed an evidence strategy aligned with U.S. dietary supplement structure/function claims, Canadian NHP cognitive support claims, and global scientific substantiation expectations