Publishing Submission Support
We are professional consultants providing strategic and technical advice as well as direction to sponsors on reducing time‐to‐submission by implementing strategies, processes and procedures related to scientific/strategic and operational aspects of drug development.
Publishing Service Offering
Publishing Service Offering
- Regulatory publishing expertise
- Regulatory publishing submission management
- Submission‐level publishing in CTD/eCTD formats
- Publishing of regulatory documents: clinical, non‐clinical, and CMC
- Preparation of compliant individual dossier sections for electronic or paper‐based submission
- Preparation of compliant electronic and paper submissions: IND, IMPD, CTA, NDA, ANDA, 505(b)(2), MAA, NDS, DMF, CSR, Annual Reports, Orphan Drug Applications, Amendments, and Supplements
- Advanced bookmarking and hyperlinking, including case report forms for electronic submissions
- Conversion of legacy documents for eCTD
- Document formatting and stylistics
- Document scanning and the restitution of scanned documents
- Document submission to FDA, EMEA and successful management of Regulatory review processes.
aguzman@consultantcr.com
Cambridge, MA 02139 | M:617.669.3566 |
Cambridge, MA 02139 | M:617.669.3566 |