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SERVICES

Documents

  • Document Formatting

  • Standard use of styles and templates

  • Submission ready documents

  • PDF Rendering and compliance checks

  • Bookmarks and Hyperlinks creation

  • Quality control on all document navigation

Submissions

  • eCTD readiness checks

  • Submission planning

  • Gap analysis

  • Granularity review

  • Report publishing

  • Submission publishing

  • Assembly

  • STF check

  • Dataset validation via CDISC compliance (ADAM, SDTM, SEND)

  • Validation

  • Dispatch

 

Lifecycle

  • Submission maintenance

  • Submission review

  • Safety Reports

  • Correspondence

  • Amendments

  • IMPDs

  • Annual Reports

  • Variations

  • Other submissions

Quality

  • Regulatory Requirements

  • Compliance

  • Electronic Submission Gateway (ESG WebTrader)

  • Training

  • Guidance support

  • Business workflow optimization

  • SOP creation

  • Vendor selection

  • User Requirements

  • Validation

  • Quality checks

Training

  • Customized training to meet your company's requirements and needs

WHAT WE DO

Documents

We offer document publishing services that meet submission needs and timelines.  Our services ensure that your documents follow the regulatory requirements.  These include:

  • Formatting documents using standard style guided templates

  • Converting documents into PDF's according to regulatory requirements

  • Creating bookmarks that match table of contents (TOC)

  • Hyperlink internal and external documents

  • Establish quality control process on all documents

Documents

WHAT WE DO

Submissions

We offer submission publishing services supporting eCTD, hybrid (NeeS) and paper submissions to global regulatory agencies.  Our services include:

  • Subject matter expertise in evolving requirements and technologies

  • Regulatory submission strategy and technology

  • Assembly

  • Submission publishing

  • Report publishing

  • Granularity review and Submission planning

  • eCTD readiness checks and Gap analysis

  • validation checks

  • Dispatch to the authority via mail, CD/DVD or gateway

 

Submission types include:

  • Report publishing (CSRs)

  • Investigational Drug Submissions (IND)

  • New Drug Applications (NDA)

  • Abbreviated Drug Applications (ANDA)

  • Drug Master File (DMF)

  • Annual reports and others...

eCTD Submissions Services

WHAT WE DO

Lifecycle

We assist you with managing the eCTD Lifecycle (LCM) of your products.  Our services include:

  • Tracking submissions

  • Fufill regulatory authority requests and perform submission maintenance through correspondances

  • Managing CMC and labeling submission requirements

  • Supporting amendments, annual safety reporting and other supplementary submissions

  • Coordinating pre and post submission requirements

Lifecycle

Helping You

Every Step of the Way!

 

We Are An Extension Of Your Company.

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Regulatory Operations &

Lifecycle Publishing Support

Supporting Your RegOps Outsourcing Needs and Projects.

 

  • We extend your capabilities by supporting you through the complete registration and submission process.

 

  • We deliver the resources you need to help you move forward with your regulatory operations’ needs.

 

Contact us and let us know how we can help.

Our Services
eCTD Submission Services2
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