What We Do?
What We Do
Regulatory Strategy & Compliance
- Natural Product Number (NPN) applications and licensing
- Bilingual label compliance and packaging review
- Global packaging reviews for regional label/claim conformity
- Ingredient classification and regulatory claims assessment
- Global regulatory filings (INDs, ANDAs, DMFs, eCTD/ACTD dossiers)
- Site reference submissions and lifecycle management
- Import/export documentation and cross-border market access
- End-to-end product licensing and regulatory support
Analytical & Scientific Services
- Method development and validation
- Dissolution, assay, impurities, friability, and compatibility studies
- Stability studies (ICH), polymorphism, and salt optimization
- Extractables, leachables, and structural elucidation using advanced instrumentation
- Support for APIs, intermediates, and KSMs (key starting materials)
Regulatory Documentation & Dossiers
- Compilation of market-specific regulatory dossiers for pharmaceutical products
- Preparation of clinical trial protocols, investigator brochures, and informed consent forms
- Development of risk assessments, safety summaries, and benefit-risk justifications
- Drafting and formatting of Common Technical Documents for global submissions
- Authoring of scientific rationales, quality overviews, and justification reports
- Management of regulatory correspondence
- Lifecycle maintenance: variation filings, renewals, and post-approval changes
Training & Knowledge Development
- Virtual training for regulatory affairs, QA/RA, and scientific professionals
- Modules on dossier writing, GMP documentation, and analytical validation
- Guidance on Health Canada, US FDA, and EMA submission pathways
- Customizable content tailored to product type and market focus
- Delivered fully online with real-world regulatory application
Food Testing & Regulatory Support
- Analytical testing of food-grade materials and finished products
- Verification of ingredient identity, purity, and contaminant levels (e.g., heavy metals, pesticides, microbes)
- Compliance review of food labels under Canadian and international food labeling regulations
- Documentation support for health claims, nutrition panels, and allergen declarations
- Safety assessments aligned with Canadian and international food safety standards