2 services found
Intrinsik Inc. Services
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Health- Pharmaceutical & Biotechnology Services
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General Services
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 ...
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Regulatory Affairs 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 ...