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.
For any drug product to be sold in the U.S. and/or Canada, it must pass through a premarket evaluation and obtain approval from Health Canada and/or the Food and Drug Administration (FDA). This endorsement is contingent upon demonstrating that the drug product is safe, efficacious, and of high quality.
At SNI, we compile a high-quality submission and assist in navigating the occasionally rigorous regulatory process, reducing time delays and expediting your product's entry into the market.
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.
To assist in obtaining or renewing 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) or non-prescription drugs must be licensed by the regulating body of the country in which they will be sold. 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 the licensing process and provide valuable knowledge to get your product into the market as quickly as possible while remaining compliant to 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 efficiently. 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
- Preparation of Drug Master Files (DMF)
- Preparation of New Drug Submissions (NDS)
- Preparation of Abbreviated New Drug Submissions (ANDS)
- Label creation and label reviews
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)
- Label creation and label reviews