Drug Regulatory Affairs

Cispact endeavours to offer the best regulatory affair services by strategically preparing a regulatory plan for development modules in clinical programs and trials. We work diligently to integrate marketing applications by overcoming issues caused by complex submissions, challenges faced in data analysis and scary deadlines. We also support regulatory publishing of applications amendments and reports to the food and Drug Administration, even in the eCTD format. Our team of excellent strategists, communicators, consultants and publicists oversee, execute and enable regulatory success through every phase of the pre-regulation, regulation & post-regulation period for drugs.

Regulatory Consulting ServicesS

  • IND Writing, Gap Analysis & Reviewing of clinical development plans, protocols & investigator brochures

  • Develop regulatory strategies to support registrations worldwide

  • IND Writing, Gap Analysis & Reviewing of administrative documents & plans

  • Support in agency meeting preparation & conduct

  • Consultations for an array of programs to treat various ailments

  • Consultations for CMC writing & non-clinical development plans

  • Consultation for FAQs and drug regulation questions including FDA queries

Regulatory Approval Services

  • Development of Phase III Pivotal Clinical Study Reports, Modules & Clinical Overview

  • Summarizing Safety (ISS), Efficacy (ISE), Clinical Efficacy (SCE) and Clinical Safety (SCS)

  • Conducting a Module 3 Gap Analysis & regulatory analysis of Application

  • Development of SDTM Compliant, ADaM Compliant and ISS/ISE Compliant datasets

  • Creation of Regulatory Briefing documents & quick Responses to Regulatory Authority Questions

  • Creation of Slides for Regulatory Presentations

  • Development of 4-Month Safety Updates & Annual Report

Regulatory Publishing Services

  • Management of project and timelines for the regulatory publishing process

  • Converting paper submissions into eCTD format

  • Taking care of document level publishing & use of standardized templates

  • Formatting styles, captions, cross-references, tables, etc in Ms Word.

  • Converting every document/file as per required standards

  • Processing of bookmarks, internal links, properties, QC in PDFs

  • Regulating Submission level publishing: eCTD placement

  • Regulating Submission quality control (QC)

  • Converting submissions to FDA via Electronic Submissions Gateway

  • Archiving final word docs and submission sequence

 At Cispact, we take regulatory affairs seriously and hence assist you through the entire drug development and regulatory submission process in our fullest potential and capabilities.