Products that are classified as pharmaceutical drugs require regulatory approval before marketing in their respective countries.
The process, timeline, and cost of applying for a pharmaceutical/drug license depends on various factors such as:
- Active ingredients
- Inactive ingredients
- Intended use (claims)
- Similarity to other products already on the market
- Compliance with a product monograph or labeling standard
- Clinical research completed on your product
- The market (country) you intend to sell into
Our team can support your pharmaceutical/drug submission, ensuring speed and budget are kept in mind throughout the project. We can also extend our support to post-market processes, ensuring that products successfully registered with regulatory authorities remain in compliance throughout their life-cycle, avoiding the risk of costly recalls. In the event a recall is ordered (or suspected necessary) for your product, we can support you throughout the process, including determining whether a recall is needed, and communicating with regulatory authorities and consumers on your behalf.
Our services are listed on the left menu. If you need to start further back in the process, please don’t hesitate to contact us for a customized quote on a facility / product evaluation, a unique service in which an expert from our team evaluates the feasibility of your product or facility, based on your plan-to-market. Our team will highlight different regulatory options available to you, and flag any potential areas of concern with your product, facility, or plan.