At De Groot Technical Services we prepare the various submissions necessary for regulatory approval prior to selling your product into the market place. Our understanding of the regulatory requirements and regulatory guidelines is available during the preparation of submissions to regulatory authorities. We provide advice on what data is required, review the suitability of existing data, and we collate all the necessary information in the format required.
We also track progress of your submission via our submission management system during the review process with the regulatory authorities. We use an internal electronic tracking system and provide regular updates on progress to our clients.
We have experience with all types of submissions including active constituent, new and image products, formulation changes and label updates.