Pharmaceuticals
Supporting drug innovation to improve global health
As the pharmaceutical market continues to evolve, our team has adapted to the current regulations and development complexities that come with commercialization.
All drugs sold in the US and Canada must undergo premarket review and be approved (a drug identification number (DIN) is issued prior to sale in Canada), To obtain approval by Health Canada and the FDA (Food and Drug Administration) drugs must be proven safe, effective and of high quality.
At SNI we compile a high-quality submission and help you navigate the sometimes-intense regulatory process, minimizing time delays and getting your product into the market as quickly as possible.
We have years of experience in compiling regulatory applications and creating compliant label solutions for over-the-counter drugs and prescription drugs.
In addition, companies involved in the fabrication, packaging/labeling, testing, importation, distribution and/or wholesaling of drugs must possess a valid Establishment License in Canada and the US. On your behalf to help you obtain or renew your Establishment License we can:
- Evaluate your site
- Develop Standard Operating Procedures
- Train your staff
- Navigate the regulatory system
OVER-THE-COUNTER DRUGS
Over-the-counter (OTC) drugs, or non-prescription drugs must be licensed by Health Canada and the FDA in order to be legal for sale in Canada and the US. A product will receive approval (and a Drug Identification Number (DIN) in Canada) once it has been determined to meet the established criteria for safety, efficacy and quality.
At SNI, our team of regulatory experts will help you through this licensing process and provide valuable knowledge to get your product into the market as quickly as possible while remaining 100% compliant to Canadian and US rules and regulations.
PRESCRIPTION DRUGS
Prescription drugs are subject to premarket review, evaluation and licensing by Health Canada and the FDA. Once products have been determined to meet established Health Canada or FDA criteria for safety, efficacy and quality they will be approved ( and issued a Drug Identification Number (DIN) in Canada) making them legal for sale.
Our regulatory team is well versed in this process and will help you get your product into the market quickly and stress-free. They have a great knowledge of Health Canada and FDA evaluation criteria regarding prescription medications and can assist you in making this process as simple as possible.
Canadian pharmaceutical services include:
- Product development consulting and strategic planning
- Drug classification and compliance
- Pharmaceutical clinical trials
- Drug classification and compliance
- Pharmaceutical clinical trials
- Preparation of Active Substance Master Files (ASMF)
- Preparation of New Drug Submissions (NDS)
- Preparation of Abbreviated New Drug Submissions (ANDS)
U.S. pharmaceutical services include:
- Product development consulting and strategic planning
- Drug classification and compliance
- Pharmaceutical clinical trials
- Preparation of US Drug Master Files (DMF)
- Preparation of New Drug Applications (NDA)
- Preparation of Abbreviated New Drug Submissions (ANDA)