Intertek experts have an unparalleled understanding of the intricacies and processes of regulatory agencies
Keeping up with the ever-changing regulatory landscape and the differing pre-market requirements for the chemicals industry 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.
At Intertek, we not only understand regulatory processes and requirements, but we are also available to follow through with the submission process and act as a liaison with regulatory agencies as required.
Our services include:
- Regulatory Interpretation
- Dossier Preparation and Stewardship
- Risk Management Negotiation Support
- In-country representation (e.g., Canadian Agent)