Regulatory Submissions Our experienced consultants will streamline your non-clinical and chemistry, manufacturing and control (CMC) sections of your IND/CTA and NDA/MAA to ensure a successful regulatory submission. In addition, we offer to prepare and submit your entire DMF and ANDA documents to US, Europe and Japan. For clients' with internal regulatory affair resources, our consultants could provide you with an independent and un-biased review of your document package prior to submission. This service reduces regulatory issues and speeds up the approval of your regulatory submissions. In addition, we provide in-company training services on non-clinical and CMC requirements.