serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Drug, Device and Biologics Applications

 PTS Consulting Global Services provides compilation, authoring, publishing and submission services for various application types. Our submission services include associated submissions in addition to the original applications (amendments, supplements, annual reports).

Drug-and-Biologics-LicensingElectronic Submissions (eCTDs)

eCTD ESG ANDA filings, 505b2 filings, IND filings, and DMF fillings. Submission of ANDAs, NDAs, INDs, and DMFs.

Paper Applications/CTD/Traditional Format

The FDA is going to require electronic filings for all submissions. We can convert paper applications to eCTD and file on the ESG (Electronic Submission Gateway)

 PTS Global Services works with our clients to determine the level of need and provide support that the client requires including necessary templates for authoring of electronic documents and regular update reports once the compilation, authoring and editing process begins.

  • Abbreviated New Drug Applications (ANDAs)
  • New Drug Applications (NDAs)
  • Investigational New Drug Applications (INDs)
  • Drug Master Files (DMFs)

 PTS Consulting Global Services provides turnkey comprehensive electronic submission services that are cost and time effective for therapeutic and diagnostic biotechnology products. We provide a wide range of services including eSubmissions.

rd2rxThrough our partnerships, we operate a secure ESG which allows direct delivery of submissions to FDA like an e-mail. No mailing, no delivery delays, critical for first to file and PIV opportunities. Compliant submissions reach division within 15 minutes of transmission.

Secure email communication with regulatory agencies results in quicker and higher response rate and can often substitute paper mails, including electronic digital signatures and certifications.

We have the capability to provide electronic NDC Labeler Code Request, Facility and Drug Registration, and DUNS number mandated by regulations in July 2009. We implemented use of FDA’s eSubmitter that allows preparation and submission of eclectic standardized electronic submissions across various FDA Divisions.

PTS Global Services include:

  • Introduction to eSubmissons their scope and advantages.
  • Elaboration upon the eSubmissons process including compilation, granularity, and lifecycle management
  • Training to your staff on electronic submissions
  • Compilation of eSubmissons , including document formatting per requirement by ICH/FDA, granularity requirement per ICH/FDA, enhanced reviewer usability (hyper linking within documents and references, bookmarks)
  • Validation of eSubmissons (testing and correcting for errors per ICH/FDA requirements to ensure acceptance by regulatory agency)
  • Submission to the agency with guaranteed acceptance to file based upon eSubmissons technical architecture (including liaison with FDA e-submission unit: prior to submission, actual submission, to follow up acceptance of submission)
  • Assistance with related electronic agency requirements like SPL/PLR (Structured Product Labeling and Physician Labeling Rule)
  • Preparation for future changes to electronic submissions (Like Regulated Product Submissions)

We also possess the capability to convert your prior paper submissions to electronic format, and hence, giving you the ability to submit future submissions electronically which saves resources, and moreover, is reviewer friendly

 

 

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