sections or complete applications for traditional pharmaceuticals,
drug delivery systems, devices:

US: IND, ANDA, NDA (CANDA), NDA supplement, DMF, Orphan Drug,
           Compassionate Use, IDE, 510(k), PMA

Canada: IND, NDS, ANDS, DMF, Compassionate Use

UK: CTX or CTC

regulatory strategy development

project management

pre-IND, end-of-phase II, pre-NDA
meetings and other necessary 
agency interactions

generic name registration

adverse event reporting

labeling and promotional review

regulatory training programs:  regulatory affairs, clinical quality assurance, 
preparing for a FDA audit

medical/technical literature
searches and analysis

medical/technical translations
(French, Spanish, English)

SOP writing

clinical compliance support

medical/technical writing (IND and NDA summaries, DMFs, clinical protocols, 
informed consent forms, final reports, labeling, Investigator Brochures, 
responses to warning letters and FDA 483s)