Support capabilities include:

Drug , OTC, medical device facility evaluations for locations throughout the world for all therapeutic product forms.
Due Diligence evaluations.
QC/QA and bioanalytical laboratory operations.
Regulatory document preparation for therapeutic products (NDA/NDS, ANDA, ANDS, IDIN, ND, IDE, 510(K), Part II Notifications, PMA, Part IV Notifications, IVDs).
Technical Writing Support.
Dietary supplements, Natural Health Products, Veterinary drugs, Animal feeds.
Training programs, documentation systems.
GMP, GCP and GLP monitoring services.
US Agency, Drug / Device Registration

Specialties include start-up environments (research, discovery laboratory operations compliance), contract operations evaluations (Bio-houses, CROs, laboratories, synthesis, packaging, manufacturing (North America and overseas).