Services ...

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
• Quality Control/Quality Assurance: accuracy, precision, consistency
• Regulatory Publishing: structure, conformity, accuracy, internal consistency
• Regulatory Services: strong foundation, experienced support, negotiated strategies
• Biostatistics: scientific planning, clear analysis, solid conclusions
• CMC: detailed methods, proof of repeatability, thorough validation
• Clinical Development: control, accountability, good practice
• Data Management: robust systems, experienced staff, file worthy data
• E-Trials: efficient processes, study control, faster database lock
• Medical Devices: quality processes, high standards, consistent product
• Health Economics and Outcomes Research: patient focuses, research driven, reality based