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Aptuit Consulting Inc
Regulatory Publishing

Regulatory Publishing

Aptuit Consulting now offers eSolutions electronic IND publishing capabilities and the more traditional paper-based publishing services. Aptuit Consulting’s eSolutions Service is an FDA electronic common technical document (eCTD) compliant publishing system that ensures that regulatory documents are formatted into submission ready products that meet all FDA and EMA standards.

Emerging companies have come to appreciate the value of structuring their product development documents in readily accessible formats early in their drug development process. Partnering with Aptuit Consulting capabilities combine the technical aspects of document production and submission with insightful regulatory expertise from Aptuit Consulting’s professional regulatory staff. If your goal is to successfully expedite your regulatory submission processes, you need look no further.

Aptuit Consulting’s team of experienced professionals will guide you through the publishing process and will ensure that your projects are completed on time and budget. Whether your project requires managing and publishing entire submissions or simply supplementing your in-house resources, we offer a flexible portfolio of professional regulatory services tailored to meet your specific needs. Through the use of our Regulatory publishing services, you can expect cutting-edge capabilities that will help drive your regulatory submission project.

Publishing Service Offering

  • Regulatory publishing expertise
  • Regulatory publishing submission management
  • Submission-level publishing in CTD/eCTD formats
  • Publishing of regulatory documents: CMC, non-clinical and clinical
  • 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, EMA and successful management of Regulatory review processes.