Regulatory Support

Regulatory Support


Our regulatory support includes assistance in the preparation of all documents required by the regulatory authorities.  This includes generation of a pre-IND meeting dossier or package, a CMC section for an IND filing, assistance with responses to questions by the reviewing agencies, visiting the regulatory authorities at the request of the client if necessary, and NDA filing.

Other services including stability studies, generation of reference standards, analytical method validation for Phase II or Phase III products, or Process Validation activities in anticipation of commercial production, will be tailored to the requirement of your product life cycle stage.