Drug Product Regulatory Affairs Services
In close collaboration with you, our Regulatory Affairs provide a CMC dossier prepared to best suit the stage of clinical development of your product manufactured by us.
Our team of more than 40 professionals is aligned with manufacturing sites around the globe and experienced in CMC dossier preparation. We excel in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications. We have worked together with our customers to apply sound scientific justifications to reduce the time and cost impact. We systematically track drug product regulatory trends and topics for the extensive number of our facilitated health authority assessments, and we apply this information towards writing your application. FDA/EMA CMC compliant templates are utilized (with internal guidance to capture all required regulatory information) as part of our customer-based quality system.
Our pharmaceutical Regulatory Affairs team exchanges information with our subject matter experts from our product development, formulation, tech transfer & manufacturing on a daily basis. Such efficient communication lines across our development and manufacturing site network are particularly valuable for drug products where an accelerated regulatory pathway has been granted.
In addition to supporting drug products developed and manufactured by us, we provide regulatory information for our media and capsules, and offer access to DMFs or CEPs to facilitate your submission.