Affiliated Services
Our expert import and QA team works with foreign manufacturers across the globe to facilitate Canadian market access for their drugs, natural health products (NHPs), medical devices, and investigational medicinal products. By using our import services, foreign clients eliminate their need for a Canadian facility, costly Establishment Licences, QA personnel and the associated infrastructure and expenses. Our services are tailored to fit clients’ needs and we can serve as Canadian importer on an ongoing basis, or during the product licence submission process.
Importation Services
- Strategic planning prior to NDS, ANDS, SNDS, and product launch
- Short term use of our Drug Establishment Licence to assist with NDS, ANDS, SNDS filing
- Long term importation of clients’ drug products, NHPs, and medical device under our licence and quality system requirements
- Liaison with Health Canada on our client’s behalf
- Importation of investigational medicinal products for clinical trials
- Manage all ongoing QA activities for imported products
- Coordinate Canadian testing, and 3PL activities
- Canadian customs brokerage
Our quality expert team routinely assist manufacturing companies and clinical supply contractors around the world.
Quality Services
- Creation and implementation of Quality Systems that meet our clients’ needs based on scope of activities and stage of development
- Assessment and remediation of existing quality systems
- Remediation of companies with serious health agency inspection problems
- Providing quality auditing services
- Acting as the QA Department for numerous clients
- Product release for use on clinical trials or for sale (APl/Finished Product/Clinical Trial Supply)
- Providing on-site Quality support
- Identification, qualification and oversight of contractors, including preparation of Quality Agreements
- Conducting site assessments and/or hosting regulatory authority inspections