We have extensive experience writing and managing the creation of Regulatory documents
for Pharmaceutical companies. Completed projects include integrated clinical and
statistical study reports, NDA Integrated Summaries of Safety, NDA Integrated Summaries
of Efficacy, and other NDA sections.
Additional Regulatory writing projects have included Clinical Investigator’s Brochures,
study Protocols, and Package Inserts.
Various types of marketing support pieces including journal manuscripts, book chapters
and other marketing aids have been produced.
Clinical Research Project Management and Planning services have also been provided.
We have experience managing multi-protocol Phase I-III
drug development programs, as well as serving as team leader for a complete clinical
trial team, including monitoring, data management, programming, statistics, medical
writing and quality assurance.