We can assist you with:
- Preparation of relevant regulatory dossier sections
- Method validation for detecting levels of the active substance in the formulated product and ‘monitoring’ methods
- Study set up and monitoring for method validation studies
- Data waivers/justifications
Our experts draw upon a wealth of experience of working with a variety of substances and formulations, taking them from the initial stages where preliminary work is required, right through to product registration.
They have a depth of experience in developing methods in order to allow for an acceptable validation result to present to the authorities, whether it be through amendments to an existing method, such as CIPAC methods, or through developing a new method from first principles to cover the analysis requirements of the relevant regulatory sector.
All work is conducted in accordance with the relevant EU guidance documents, using approved formats and systems.