Expertise

Experience in all development phases and several therapeutic areas, including:
  • oncology
  • metabolism
  • CNS
  • respiratory
  • arthritis
  • anti-infectives

Cumulative experience of over 25 years preparing clinical documentation, including IND/CTX documents, study protocols and reports, investigator brochures, etc.

More than 16 submission dossiers (both MAAs and NDAs); at least 7 in the CTD format.

Consultants for oral explanations/advisory committee hearings and support providers for preparation of answer packages to questions from authorities.

A proven record of producing high-quality documentation, with commendations from the European and US authorities, as well as from the teams we have worked with. Our customers choose to work with us repeatedly because they are satisfied with the quality of our work and they know we can deliver to the demanding timelines typical for the industry.

Years of working together have resulted in the Trilogy Writing partners becoming a synergistic team that is flexible and produces effective documentation.


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