Pre- and Post-Submission Support for Global Regulatory Compliance

At CLINZTECH, we specialize in providing end-to-end regulatory submission services to support pharmaceutical and API manufacturers across global markets. From dossier compilation to post-submission lifecycle management, our regulatory experts ensure that your submissions meet the highest standards of accuracy, format, and compliance—accelerating approval timelines and reducing regulatory risk.

Pre-Submission Services

1. Drug Master File (DMF) Compilation

• US and Europe Markets (Modules 1, 2, and 3)
  Using Knowledge Net Software, we ensure seamless compilation of DMFs in eCTD format as per current FDA and EMA guidelines.
• Brazil (ANVISA) and Rest of World (ROW) Markets
  Specialized compilation of dossiers tailored to ANVISA’s Module 1 specifications and region-specific regulatory requirements.
• India (DCGI/CDSCO)
  Compilation and submission of Type I/II/III DMFs per Indian regulations, with full compliance to DCGI/CDSCO guidance.

2. Certification and Compliance Submissions

• Certificate of Suitability (CEP)
  Preparation and submission to the European Directorate for the Quality of Medicines (EDQM) to demonstrate compliance with the European Pharmacopoeia monographs.
• Active Substance Master File (ASMF)
  Structured compilation for submission to the European Medicines Agency (EMA) and other national competent authorities in the EU.

3. Technical Review and Documentation Support

• Chemistry, Manufacturing, and Control (CMC) Review
  In-depth review of CMC data and documents to ensure technical accuracy and regulatory alignment for Module 3.
• Technical Documentation Evaluation
  Expert review of documents received from customers to verify completeness, accuracy, and readiness for regulatory filing.
• Quality Overall Summary (QOS)
  Preparation of a concise and comprehensive QOS for Module 2, summarizing critical quality-related information from Module 3.

eCTD Filing and Lifecycle Management

• eCTD Compilation and Submission (US & Europe)
  Fully compliant electronic Common Technical Document (eCTD) submissions using Knowledge Net Software, aligned with FDA, EMA, and ICH guidelines.
• Submission Readiness and Formatting
  Document formatting, hyper-linking, bookmarking, and validation to ensure eCTD structure integrity.

Post-Submission Services

Our regulatory services don’t end at submission—we provide full post-submission support to maintain compliance throughout the product lifecycle.

• Annual Reports and Amendments
  Preparation and timely submission of annual updates and amendments to meet evolving regulatory requirements and changes in manufacturing or control.
• Variation Filings
  Compilation and submission of Type IA, IB, and II variations for the EU and applicable change notifications for other markets.
• Regulatory Intelligence and Strategy
  Ongoing tracking of regional regulatory changes to guide clients on necessary updates or documentation revisions.

Why CLINZTECH?

• Regulatory Expertise Across Markets
  In-depth knowledge of FDA, EMA, ANVISA, EDQM, DCGI, and ROW requirements.
• Technical Accuracy & Compliance
  Thorough review of scientific and technical documents to ensure consistency, completeness, and regulatory compliance.
• Software-Driven Precision
  Use of Knowledge Net Software for eCTD compilation, document validation, and structured submission.
• Global Submission Support
  End-to-end regulatory support across North America, Europe, South America, Asia, and Africa.
• Timely Submissions and Support
  Our streamlined approach ensures that all documents are compiled, reviewed, and submitted on time, every time.

Whether you’re preparing for initial submission or managing post-approval changes, CLINZTECH provides the regulatory expertise and technology support needed to ensure a smooth, efficient, and compliant submission process across all markets.