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Regulatory Operations Publishing

Welcome to SubmitWise, your trusted consultant for regulatory compliance solutions.

Meeting with client

We are dedicated to providing expert guidance and support to help businesses navigate complex regulatory requirements.

Services

Staff Augmentation

For your work in regulatory publishing and submission, staff augmentation can be a great option when facing tight deadlines, regulatory expertise gaps, or increased workload due to submissions. This approach lets you bring in specialists for tasks like document authoring, quality checks, or even specific tool expertise, ensuring timely and compliant submissions without straining your core team.

Key benefits include:

  1. Cost Efficiency: Avoids the expense of hiring full-time staff by using temporary resources only when needed.

  2. Access to Expertise: Provides access to highly specialized skills without a long-term commitment.

  3. Flexibility: Scales the team up or down based on project demands.

  4. Faster Hiring Process: Reduces the time spent on recruitment, as staff are sourced from specialized vendors or agencies.

Document Formatting

1. Formatting Standards and Guidelines​​​

2. Table of Contents and Bookmarks​​

3. Consistency and Style​

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Pre-Publishing

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  1. Document Preparation

  2. Validation

  3. Publishing

  4. Quality Assurance (QA)

  5. Compliance Review

 

Build Submission

1. Create External links

2. Metadata Assignment

3. Compilation and Linking

4. Technical Compliance Check

5. Submission Creation

6. Submission and Archiving

 

Sphere on Spiral Stairs

Services

Training

Publishing a regulatory submission involves multiple steps and tools, often specific to the regulatory authority and product type.

1. Document Preparation

  • Purpose: Know the structure, templates, and format needed for each submission type.

  • Training Items:

    • Document types (e.g., Module 1-5 for eCTD)

    • Formatting and bookmarking requirements

    • Naming conventions and metadata

2. Publishing Software Familiarization

  • Purpose: Gain proficiency in tools like Veeva Vault RIM, ISIToolbox, and Lorenz DocuBridge.

  • Training Items:

    • Basic and advanced functionalities of publishing software

    • Importing, organizing, and editing documents within the system

    • Linking, cross-referencing, and validation tools

3. Compilation and Validation

  • Purpose: Assemble documents according to submission structure and ensure they meet validation standards.

  • Training Items:

    • Compilation process and quality checks

    • Validation software training (e.g., Lorenz Validator)

    • Addressing validation errors and troubleshooting

4. Submission Testing and Finalization

  • Purpose: Conduct final testing before submission to ensure everything works seamlessly.

  • Training Items:

    • Test submissions (e.g., through regulatory portals)

    • Electronic signature processes, if needed

    • Common troubleshooting and backup procedures

5. Submission to Regulatory Authority

  • Purpose: Submit the final package in the required format to the regulatory authority.

  • Training Items:

    • Portal familiarization (e.g., FDA ESG, Gateway)

    • Submission confirmation and receipt management

    • Archival procedures for regulatory audits and future reference

Who We Are

We have 25 years of experience, and provide end-to-end support in the preparation, publishing, and submission of regulatory documents across various electronic platforms, including eCTD.

SubmitWise LLC is a leading consultancy firm specializing in regulatory operations and compliance management. Our team of experts offers tailored solutions to ensure businesses meet regulatory standards and operate efficiently within their industries. With a focus on precision and excellence, we strive to empower organizations to thrive in highly regulated environments and achieve sustainable growth.

Vision

To be a leading provider of innovative and efficient regulatory operation publishing solutions, enabling pharmaceutical and life sciences companies to accelerate product approvals, ensure compliance, and ultimately improve patient outcomes worldwide.

Leadership

Joshua Kim

Consultant Regulatory Operations Publishing

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•A highly skilled Regulatory Professional with extensive experience in regulatory document publishing across a broad range of submissions, including ANDA, eNDA, eIND, eCTD, CDRH, and CTA submissions. Fluent in quality control (QC) and document formatting, including the creation of bookmarks and hyperlinks, with a strong focus on publishing across Modules 1 to 5 of the Common Technical Document (CTD).

•Expert in compiling and publishing complex Clinical Study Reports (CSRs) and their appendices, Protocols and Amendments, Development Safety Update Reports (DSURs), Investigator's Brochures (IBs), Chemistry, Manufacturing, and Controls (CMC) documents, as well as promotional materials (OPDP) and Case Report Forms (CRFs) for regulatory submissions.

•Experienced in using advanced publishing tools and platforms, including DocuBridge, eCTDXpress, ISI Toolbox (DXC Toolbox), StartingPoint, Veeva Vault, SharePoint, Documentum.

•Committed to delivering high-quality, compliant submissions with strong attention to detail and efficiency in the regulatory publishing process.

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