Regulatory

Keeping up with the ever-changing regulatory landscape and the differing pre-market requirements for the food, supplement, and animal feed industries is challenging. If your product falls into more than one regulatory category in multiple jurisdictions, the challenges are even greater. Developing a well thought-out regulatory strategy is key to identifying the most efficient route to market for any product, whether you wish to gain approval in one or one hundred jurisdictions.

A good regulatory strategy will outline the scientific and technical data requirements for each market of interest, identify any data gaps that will need to be addressed prior to submission, consider time lines for approval, and set forth the best approach to ensure timely and successful product approvals.

Intertek Cantox, has an unparalleled understanding of the intricacies and processes of regulatory agencies and requirements not only to develop a successful strategy, but also to follow through with the submission process and act as a liaison with regulatory agencies as required.

Our services include:

• Designing regulatory strategies to meet international requirements and pre-empt regulatory concerns in one or multiple jurisdictions;
• Preparing submissions, from pre-meeting packages and post-marketing changes, to complete dossiers for new active substances for regulatory agencies worldwide;
• Liaising with regulatory agencies, including facilitating meetings and providing independent, third-party critical advice on and responses to regulatory issues;
• Developing global regulatory monitoring programs to ensure that products remain compliant in changing regulatory climates; and
• Designing, placing and monitoring pre-clinical and clinical studies to ensure completeness of the safety and/or efficacy evidence base for regulatory submissions.