Our team of experienced regulatory experts is well-versed in the latest regulatory requirements and can assist with a wide range of regulatory activities.
We can develop robust and validated analytical methods for the analysis of your products, ensuring that they meet the required quality standards.
We can validate your analytical methods according to regulatory guidelines, providing evidence of their accuracy, precision, specificity, linearity, range, and robustness.
We can conduct stability studies to assess the stability of your products under various storage conditions, ensuring their shelf life and quality.
We can assist with the preparation of Drug Master Files (DMFs) and Common Technical Documents (CTDs) for regulatory submissions. Our expertise in regulatory documentation ensures that your submissions are complete, accurate, and compliant with regulatory requirements.