Helping clients achieve regulatory compliance and obtain product approval is our ultimate goal.
Since 2009, we have been helping clients achieve regulatory compliance.
Regulatory expertise surpassing 10 years of regulatory affairs & compliance experience covering multiple regulatory jurisdictions (e.g. FDA, Health Canada, TGA, EU) and numerous product categories including medical devices, drug products, combination products, natural health products, and cosmetics.
Experienced in navigating through various regulatory frameworks and developing effective regulatory strategies to deliver regulatory agency approval, authoring various types of regulatory submissions, interacting with regulatory agencies during review, and managing post-approval changes.
Why work with us?
Serving our client’s regulatory needs is our #1 priority. We strive to ensure that the expected results are delivered in a timely and efficient manner to help you get your product onto the market! We welcome projects of various degrees of complexity and greatly enjoy rising to the challenge!
Over the last decade we have encountered numerous scenarios where we have successfully negotiated with the regulatory agency to get products approved.
Our primary objective is to provide exceptional service to our clients by not only meeting, but by exceeding expectations.