Document Preparation and Regulatory Submissions

Preparation of documents and submissions (including CANDA) required by health authorities using state-of-the-art technology (Xerox DocuTech™ and electronic media). Collaboration with the sponsor to review and evaluate data in the context of health authority regulatory requirements. Representation of the sponsor in regulatory negotiations and health authority meetings. Preparation of development plans, synopses, reports, and summaries.

  • Investigator brochures
  • IND/CTX applications
  • Protocols
  • Statistical analysis plans
  • Preclinical study reports
  • Clinical study reports
  • Serious adverse event reporting
  • Presentations to health authorities
  • Method/Process validation reports
  • Expert reports
  • Worldwide data summaries
  • Market applications (NDA/dossiers)
  • Responses to rapporteurs
  • BLA/PLA/ELA
  • Investigational device exemptions
  • 510K applications


Trial Initiation and Monitoring | Data Management | Data Analysis and Evaluation
Document Preparation and Regulatory Submissions | Quality Assurance

One Main Street  Chatham, NJ 07928 USA  Phone: 1.973.635.9898  Fax: 1.973.635.9881