Medical and Regulatory Writing

Cayuga's group of experienced contract medical writers, statisticians, programmers and QA Auditors possess highly competitive expertise in data analysis, medical writing and medical communication of all types. A proven track record of success in all phases of clinical development writing allows Cayuga Consulting to provide each client the highest quality deliverables in the most cost-efficient and timely manner.

Cayuga Consulting also provides a wide range of experience in clinical drug development, encompassing all phases of clinical trial design and management, preparation and submission of NDAs, BLAs, ANDA, 505(b)(2), PMA and 510k submissions, safety surveillance, data analysis, and preparation of reports. (Clinical Research and Development).

Types of documents prepared:

• Clinical Study Documents
• Protocols, Protocol Amendments, and ICFs
• Informed Consent Forms
• Investigational Drug Brochures
• Study Manuals
• Clinical Study Reports (all phases including Phase 1 and Postmarketing)
• Integrated Summaries of Efficacy and Safety for NDA/BLA submissions
• IND, Investigator INDs, Annual Reports, Periodic Safety Update Reports, Patient Safety Narratives
• NDA, BLA, 505(b)(2) and ANDA submissions in eCTD format
• Reviews, Systematic Overviews, Meta-Analyses, and White Papers
• Posters and Presentations
• Position papers, review articles, practice guidelines, comprehensive annotated bibliographies efficiently prepared
• Product Labelling in Word — US Structured Product Language (SPL) or EU Summary of Product Characteristics (SmPC)
• Company Core Data Sheets (CCDS)

For regulatory affairs support for medical devices (PMA, 510k, CER, and supplements) contact Stephanie Rais at Strategic Drug/Device Regulatory Services (SDRS)

E-Mail: dwalczak@cayugaconsult.com