DMF/Dossier/Regulatory

Submission and eCTD Services

Docent Pharma has wide experience of producing submissions to all major health authorities worldwide. We cover North & South America, Europe, Middle East and African countries, Asian countries, CIS countries, Australia & New Zealand and beyond. 

Docent Pharma is providing regulatory advice, solutions and support for every regulatory submission requirement. 

Docent Pharma Expertise/Advantage

Quick submission turnaround times

Global eCTD Publishing and Submission Services

Highly Skilled & Flexible Regulatory Affairs Specialists for compilation and submission

Well-versed Regulatory team keeping track of ever Regulatory guidelines/changes

Expert advice on region-specific submission requirements and various other Regulatory submission formats

Docent Pharma offers the following Drug Master File services:

  • DMF compilation in CTD/eCTD Format / Country Specific format
  • Open & Close Part DMF writing and Review of DMF For Submission
  • Publishing of DMF in eCTD/NeeS/PDF as per country-specific requirements
  • USDMF Preparation and Submission 
  • European Certificate of Suitability (CEP) Preparation and Submission 
  • EU-ASMF Preparation and Submission
  • Canada-Master Files (MF) Preparation and Submission  
  • Serve as DMF Regulatory Agent/Authorized DMF Agent or DMF Point of contact for US and Canada
  • Creating Baseline submissions for paper DMFs
  • Conversion of paper DMFs to electronic DMFs
  • Maintaining the lifecycle of the DMFs
  • Preparation of regulatory strategy and response to DMF-Health Authorities queries for quick approval of drug product submissions/MAAs
  • Regulatory assessment of post-approval changes and preparation of variation submission strategy
  • Assistance to API manufacturer/DMF Applicant in pre-assigned application number request for eCTD DMF submissions

Docent Pharma offers the following Dossier services:

  • Dossier submissions in various formats (eCTD, CTD, NeeS, National, ASEAN etc.)
  • Gap analysis/Assessment of submission documents
  • Preparation and submission of dossiers (New Drug Applications [NDAs], Abbreviated New Drug Applications [ANDAs], New Drug Submission [NDS], Abbreviated New Drug Submission [ANDS],) for new and generic drugs
  • Investigational New Drug – IND Application (Pharmaceutical and Biologics) 
  • Clinical Trial Application (CTA) Preparation and Submission
  • Biological License Application (BLA) Preparation and Submission
  • Investigational Medicinal Product Dossier (IMPD)
  • Marketing Authorization Application (MAA) to Europe via Centralized Procedure (CP) or National Procedure (NP) or Mutual Recognition Procedure (MCP) or Decentralized Procedure (DCP)
  • MAAs for Australia and New Zealand
  • Dossiers for Emerging Countries
  • Assistance/Addressing Health Authorities queries in the stipulated time frame
  • Support in Post-approval changes submission strategy for the proposed changes to maintain the compliance and to submit Supplement/ Variation/Amendment to minimize the manufacturing/Regulatory cost to the client and for quicker approval
  • Support in Registered Dossier Extension