Our Services

​Regulatory Submission Types We Handle Weekly

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• FDA eCTD Publishing Services -
  Expert preparation, compilation, and submission of electronic Common Technical Document (eCTD) submissions to meet FDA regulatory requirements

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• EMA eCTD Publishing Services -
  Seamless eCTD publishing for the European Medicines Agency (EMA), ensuring compliance with EU regulatory standards

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• Rest of World (ROW) & NeeS Publishing -
  Comprehensive submission support for global markets, including Non-eCTD electronic Submissions (NeeS), tailored to specific regional requirements.

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• Regulatory Document Preparation -
  Professional preparation, formatting, and quality checks of regulatory documents to ensure submission readiness and compliance.

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• Lifecycle Management Submissions -
  Ongoing support for post-approval regulatory activities, including variations, renewals, amendments, and regulatory updates.

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• Investigator-Initiated Submissions - 
  Assistance with regulatory submissions for investigator-led clinical trials, ensuring compliance with international guidelines

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Specialized Regulatory Applications

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• Investigational New Drug (IND) Applications -
  Full support for preparing and submitting IND applications to initiate clinical trials in the United States.

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• New Drug Application (NDA) Submissions -
  Comprehensive NDA submission services to secure product approvals from regulatory authorities.

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• Abbreviated New Drug Application (ANDA) Submissions - 
  Efficient preparation and submission of ANDAs for generic drug approvals, ensuring timely market entry.

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• Marketing Authorization Application (MAA) Submissions - 
  Expert MAA submission services for the European Union and other global markets, supporting both centralized and decentralized procedures.

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• Biologics License Application (BLA) Submissions - 
  Specialized regulatory support for preparing and submitting BLAs for biologic product approvals.

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• Clinical Trial Application (CTA) Submissions - 
  Global CTA submission services to support the initiation and management of clinical trials in compliance with regional regulations.

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• Drug Master File (DMF) Submissions - 
  Preparation, submission, and maintenance of DMFs to ensure compliance with regulatory requirements for drug substances, excipients, and packaging materials.