Our first step is always to discuss your organisation, opportunities, product portfolio, the quality and availability of data and documents and your timelines. We will also highlight relevant parts of the applicable regulations, and how our services match with both your context and the regulatory requirements.
Important input at this stage is information about your product positioning, marketing claims, the exact qualitative and quantitative composition of your formulations, and the availability of substantiation for the shelf-life and period after opening (PAO) of the portfolio.
We are flexible to set-up an introductory (video) call at a day and time that is convenient to you.
Once received, we will scan your formulations for regulatory compliance, review your documents and data on quality and completeness, and have one of our experts perform a high-level review to voice any potential safety related concerns.
The prescan will provide you insights in the possibilities, steps to take, lead-times and the needed resources to have your products notified (EU/UK) or listed. Once notified/listed you are ready for sales.