Quality Control, Medical Writing, Statistics, Quality Assurance, Programming, Data Management, Regulatory/Clinical Development/Project Management and Dossier Submission Services include but are not limited
to: CSR, IND, NDA, ANDa, Annual Reports, BLA, IMPD, MAA, IDE, 510K, PMA, Safety Updates, PSUR, Bridging Reports and Narratives, Briefing Documents, ISS, ISE, PI, IB, eCTD Summaries and Overviews, protocols, clinical and safety summaries, PLA, ELA, registration documents audits and quality control reports.
Highlights of Guidance Services related to QC/QA/Submissions
Compliance Programs: competence, controlled systems, good science
Medical Writing: science, clarity, structure, storyline