|
CRM’s Regulatory Operations group offers technical writing and publishing of regulatory documents including pre-Investigational New Drug (IND) packages, IND applications, annual reports and IND amendments.
Program Management (submissions-related):
- Overall guidance for regulatory compliance with IND components required to submit an application to commence Phase I trials.
- Project coordination during the development of pre-IND package, IND application, subsequent IND amendments or technical responses to the agency.
- Review and preparation of critical materials required in IND applications: BSE risk assessments, manufacturing/testing descriptions.
Technical/Medical Writing:
- Technical writing, editing, and formatting of drafts and related materials for pre-IND’s, IND applications, IND amendments, final reports, or technical summaries.
- Drafting of scientific papers or technical abstracts.
- Technical writing for Chemistry, Manufacturing and Control (CMC) sections from Batch Production Records for an IND application.
- Development of flowcharts and tables for manufacturing processes.
- Formatting the list of references and retrieving reproducible copies of reference materials for inclusion with submissions.
- Quality control evaluation of regulatory documents to ensure consistency and accuracy prior to FDA submission.
Publishing:
- Publishing services: document cover sheets, cover labels, tabs, and page numbering.
- Reproduction services: both B&W and color, for all types of regulatory submissions.
- Document assembly and binding.
- Quality control services on all documents prior to submission.
Demonstrated Experience...
| CRM regulatory and technical writers have drafted Chemistry, Manufacturing & Controls sections for Investigational New Drug (IND) applications. The staff has successfully managed the entire IND development process including coordinating editorial reviews, compiling reference materials, and publishing the final document. |
To request more information concerning CRM’s contract services, collaborative support, management support and/or on-site staffing, contact CRM’s business development office at 301-620-1987 or busdev@clinicalrm.com.
|
