Kashbon Consulting
Advancing health products towards Commercial success
We work with therapeutics, consumer health products, food products, and medical devices.
We provide the following consulting services:
Early Development
This section supports all health product development. These are some of the most requested services. Please reach out if you require any other specific support.
Product Development
Preparation of a product roadmap and an IP strategy for success.
Financing Strategy
Assist with application for Government grants and funding opportunities.
Assist in communicating and publishing scientific research and clinical data
SR&ED Tax Credit
Assist in navigating and developing proper documentation for Scientific and Experimental tax incentives in Canada.
Therapeutics
This section is specific for therapeutic development and commercialization. Many OTC products fall into this category although they may not require physician prescriptions. Please reach out for further information or specific enquiries.
IND and CTA
Preclinical research evaluation and regulatory support for Investigational New Drug (IND) applications to the FDA and a Clinical Trial Applications (CTA) to Health Canada for therapeutics
IRB and REB
Assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
NDA and NDS
Regulatory support for both New Drug Application (NDA) and New Drug Submissions (NDS) to Health Canada
Medical Devices
This section is specific for medical device development and commercialization. These are some of the most requested services. Please reach out if you require any other specific support.
IDE and ITA
Preclinical research evaluation and regulatory support for Investigational Device Exemption (IDE) application to FDA and an Investigational Testing Authorization (ITA) application to Health Canada for Medical devices
IRB and REB
Assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
510K, PMA and MDL
Regulatory support for both 510k Pre-market Notification and Pre-market Approval applications to the FDA and Medical Device License (MDL) applications to Health Canada
Consumer Health Products
Consumer health products are sold directly to consumers. Consumer health products include Disinfectants (contact lens solution), Cosmetics (e.g., make-up, shampoos), and
Dietary supplements/ Natural health products (e.g., vitamin and mineral supplements, traditional and homeopathic medicines, probiotics, toothpastes). Please see therapeutics section for OTC drug products.
Preclinical research
Product formulation and preclinical research evaluation. Cosmetics are FDA and Health Canada regulated not approved. But the consumer product experience is paramount.
IRB and REB
Assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
NDI and NPN
Regulatory support for New Dietary Ingredient (NDI) application to the FDA and a Natural Health Product Number (NPN) application to Health Canada. proper label development is crucial
Advisory Services
No two businesses are alike. Our advisory services will differ for each client. Please contact us for evaluating your unique situation.
Business valuation
This generally involves analysis of market potential, analysis of resilience and risk, fair market value, discounted cashflow, and anything that could impact your business operations.
Technology Readiness
Concise review of the design, technological advancement, clinical use, and future potential analysis, all supported with strong scientific evidence in primary literature.
Regulatory Compliance
Safety audits, Quality and Compliance of manufacturing and packaging processes
M&A
Advisory support for successful mergers and acquisitions with technology driven companies.