Leverage our experience of working with Health Canada and FDA to achieve your company’s regulatory affairs goals.
We provide regulatory assessment, strategy, and guidance to build project models that meet your unique needs and budgets.
Key Services We Offer
Services
- CFIA Federal Establishment Registration
- Food Labelling, Health Claims and Nutrition Facts Table (NFT)
- Claim Substantiation
- Temporary Market Authorization (TMA) Applications
- Post market (License amendments and renewals)
Services
- Cultivation or processing License
- Preparation for Cannabis Drug License and DEL
Services
- Review Labels, Inserts, Monographs (USA and Canada)
- Review ingredients
- Prepare and submit DIN, NDS, ANDS, NCs, sNDS, sANDS, Annual Notification, US Annual Report, CBE30, ANDA
- Drug Establishment License
- Product Classification (USA and Canada)
- Prepare Deficiency and Clar-email/Clarifax response
- Organize pre-submission meetings
Services
- Establishment License submission and maintenance
- YBPR, Post Marketing sNDS, NCs, Deviation Reports
- DeficiencyResponse
Services
- CNF preparation and submission
- Product Classification (USA and Canada)
- Advice on labeling, claims and warning (USA and Canada)
- Ingredient search and formulation review for compliance
- Voluntary Product Registration program (USA)
Services
- NHP/ Dietary Supplement Product Licensing (USA and Canada)
- Health Claim Substantiation & Product Development (USA and Canada)
- NHP Site Licensing
- Post Marketing Amendment and Renewal applications
- Adverse Event Reporting
Services
- Label Reviews and Classification of Products
- Prepare and Submit Applications for Class II, III or IV
- Post Market Amendment and Renewal applications
- Medical Device Establishment License submission and maintenance
- Organize pre-submission meetings
Services
- Prepare and submit Veterinary ANDS and NNs
- Post Marketing Amendment and Renewal applications
Services
- e-Pesticide submission
- Post Marketing Amendment and Renewal applications
- Adverse Event Reporting
- Label review and advise
- Incident Reporting
- Organize pre-submission meetings
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Contact us and see if we can help or connect you to someone who can.