DIN submissions for Prescription & Non-Prescription Pharmaceuticals, Disinfectants and Sanitizers with Disinfectant claims
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Registration services for Natural Health Products and Homeopathic remedies
Product development, registration and commercialization expertise for food and beverage brands.
Medical device classification and registration of Class II, Class III and Class IV with Health Canada.
Real-world experience to support seamless Canadian, U.S FDA and international regulatory submissions.
Licensing, Compliance Programs, Standard Operating Procedures
NHP and Food Product Development and Formulation, Reformulation and Optimization
License Applications, Registrations and Renewals, Compliance Reviews, Notifications and Programs, Exporting to Canada
Documentation and Reports, Post-Market Compliance, Audits, Training Programs
Internal Audits, Supplier Audits, Regulatory Inspection Readiness, Quality System Assessments, Gap Analyses, CAPA Evaluation, Mock Audits, Auditor Training
Production Validation and Qualification, Documentation, Audits, Training Programs, Analytical Testing, Method Development and Validation, Stability Programs, Quality Control Strategy, Regulatory Compliance Support
Process Validation, Equipment Qualification, Cleaning Validation, Computer System Validation, Method Validation, Packaging Validation, Protocol Development, Validation Master Planning
