When a given project approaches the clinical phases the interaction with regulatory authorities becomes an important challenge. An extensive understanding of the regulatory demands and the Quality by Design concept is necessary in order to handle and progress reoccurring interactions with corresponding regulatory authorities.
Adroit Science can provide advice on how to progress and formulate adequate documentation and/or applications towards regulatory authorities for clinical studies. From involvement in numerous drug projects during many years and many interactions in the field we have obtained a dedicated “toolbox” of approaching strategies providing the adequate support for successful approvals. This includes help with
- Appropriately addressing the relation between chosen solid form and safety/performance/efficacy aspects, including advice in setting specifications (ICH Q6A)
- Solid state related pharmaceutical development aspects (ICH Q8)
- Performing a thorough risk assessment and guiding our clients through the quality by design and process validation work (ICH Q9)