Consultant - Regulatory Affairs - Outsource - Alonso Guzman
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Publishing Submission Support

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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
  • 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  |
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