A Quality Team Performing Quality Work

The types of regulatory documents required for a marketing application are numerous and complex. Because these documents represent many different disciplines and years of research and data critical for drug development, regulatory reviewers require documents to be written with specific content and in specific formats. Manual document management processes and disparate systems cultivate vast inefficiencies as sponsors struggle with:

• Maintaining version control of documents
• Changing regulatory requirements
• Handling document review and approval processes

These inefficiencies may lead to submission delays, increased costs, and the risk of nonacceptance of your submission.

A comprehensive, process-driven document quality and management program will provide assurance that your regulatory documents are compliant and of the highest quality. While Synchrogenix writing teams support content creation, editorial teams are available to manage document management processes.

Synchrogenix’s document quality and management team of regulatory writers and technical editors assures the efficient and effective management and review of your regulatory documents. All of Synchrogenix’s quality control (QC) qualified staff undergoes thorough training, including objective assessments and peer review, to qualify as a QC reviewer. Lead technical editors act as project managers and provide leadership and oversight for all QC-related activities for a client.

Over the past five years, Synchrogenix’s document quality and management team have QCed over 6,700 CMC, nonclinical, and clinical documents that contributed to successful regulatory submissions for sponsors.