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