Submission strategy, preparation and support for investigational and marketing applications (IND, NDA, sNDA, ANDA, CTD, Drug Master Files)

Required regulatory report development and preparation, such as IND and NDA Annual Reports, promotional material review and submission, NDC drug listing, adverse event reporting

Applications for Orphan Product Designation

Post-marketing regulatory affairs support for recalls or product issues

Regulatory drug development strategies

Establishment of procedures to ensure regulatory compliance

Life cycle management initiatives

Day-to-day regulatory affairs operations and guidance