Intrinsik Inc. services

Interaction with regulatory authorities on behalf of clients; Paper and Electronic applications to support; Clinical trials; Marketing applications; and, Post approval and lifecycle management; Support for regulatory consultation meetings; Regulatory strategy; Identifying opportunities for expedited approval; Issue resolution; Negotiations; and, Act as US agent and Canadian regulatory representative.

Product development and registration strategies; Scientific writing by qualified experts; Document authoring from source data; CTD summaries; Medical ; Nonclinical; Chemistry and Manufacturing; and, Investigator`s Brochures. Data reviews and gap analyses; and,Investment due diligence (In-licensing, scientific and regulatory due diligence, and technical support).