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 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
