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CMC Authoring

At RegWeb we understand the complexity of different molecules and streamline the information based on the type of application. We provide high-quality authoring by adhering to good documentation practice with attention to detail. We perform CMC authoring of Cell and Gene Therapy (CGT) products, biological products, small molecules and Active Pharmaceutical Ingredients (API). 

Types of Submissions at Different Stages

Clinical Development

  • Briefing Packages
  • Clinical Trial Applications (CTA)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Investigational New Drug (IND) Applications
  • Meeting Requests


  • 505b(2) Submissions
  • Abbreviated New Drug Applications (ANDA)
  • Abbreviated New Drug Submissions (ANDS)
  • Active Substance Master Files (ASMF)
  • Biological Licence Applications (BLA)
  • Canadian Master Files (MF)
  • Certificate of Suitability (CoS) Dossiers
  • Marketing Authorisation Applications (MAA)
  • New Drug Applications (NDA)
  • New Drug Submissions (NDS)
  • US Drug Master Files (US DMF)


  • Annual Reports
  • DMF Amendments 
  • Licence Renewals
  • Supplements
  • Variations

What our clients say

Our clients are the best testament to our acumen and capability.

“We have had the pleasure of working with our partners at RegWeb for several years across many clients and regions. The team are extremely detail orientated and organised when preparing their excellent written documents for regulatory submissions. Additionally, the team are very personable and integrate into projects seamlessly, they are our trusted partners in North America and we continue to build a Rapport year on year!”

Ifty Saiyed

EVP, Head of Global Regulatory Affairs RApport Global Strategic Services Ltd

“We from Clarivate Cortellis CMC intelligence team glad to provide this testimony to the work done by RegWeb team on providing the professional services to develop and further maintain the CMC Intelligence database. RegWeb consulting team have always done their best to meet the exact requirements of the CMC project and helped us to achieve the internal milestones to publish the content for Biologics development for identified Regulatory entities across the globe. And now we are pleased to extend their services for Small molecules maintenance as well.”

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